Pandemrix

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



 

2 

This medicinal product is subject to additional monitoring. This will allow quick identification of new 
safety information. Healthcare professionals are asked to report any suspected adverse reactions. See 
section 4.8 for how to report adverse reactions. 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pandemrix suspension and emulsion for emulsion for injection. 
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
After mixing, 1 dose (0.5 ml) contains: 
 
Split influenza virus, inactivated, containing antigen* equivalent to: 
 
A/California/07/2009 (H1N1) derived strain used NYMC X-179A  3.75 micrograms** 
 
* propagated in eggs 
** haemagglutinin  
 
AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and 
polysorbate 80 (4.86 milligrams) 
 
The suspension and emulsion, once mixed, form a multidose vaccine in a vial.  See section 6.5 for the 
number of doses per vial. 
 
Excipient with known effect  
The vaccine contains 5 micrograms thiomersal 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension and emulsion for emulsion for injection. 
The suspension is a colourless light opalescent liquid. 
The emulsion is a whitish to yellowish homogeneous milky liquid. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Prophylaxis of influenza caused by A (H1N1)v 2009 virus. Pandemrix should only be used if the 
recommended annual seasonal trivalent/quadrivalent influenza vaccines are not available and if 
immunisation against (H1N1)v is considered necessary (see sections 4.4 and 4.8).  
 
Pandemrix should be used in accordance with Official Guidance. 
 
4.2 Posology and method of administration 
 
Posology 
 



 

3 

The dose recommendations take into account the safety and immunogenicity data from clinical studies in 
healthy subjects  
See sections 4.4, 4.8 and 5.1 for details. 
 
No data are available in children aged less than 6 months. 
 
Adults aged 18 years and older: 
One dose of 0.5 ml at an elected date. 
Immunogenicity data obtained at three weeks after one dose of Pandemrix (H1N1)v suggest that a single 
dose may be sufficient.  
If a second dose is administered there should be an interval of at least three weeks between the first and 
the second dose. 
See section 5.1 regarding immune responses to one and two doses of Pandemrix (H1N1)v, including 
antibody levels after 6 and 12 months. 
 
Paediatric population 
 
Children and adolescents aged 10-17 years 
Dosing may be in accordance with the recommendations for adults.   
 
Children aged from 6 months to 9 years 
One dose of 0.25 ml at an elected date.  
There is a further immune response to a second dose of 0.25 ml administered after an interval of three 
weeks. 
 
The use of a second dose should take into consideration the information provided in sections 4.4, 4.8 and 
5.1. 
 
Children aged less than 6 months 
No data are available. 
 
It is recommended that subjects who receive a first dose of Pandemrix should complete the vaccination 
course with Pandemrix (see section 4.4). 
 
Method of administration 
 
Immunisation should be carried out by intramuscular injection preferably into the deltoid muscle or 
anterolateral thigh (depending on the muscle mass). 
 
For instructions on mixing of the medicinal product before administration, see section 6.6. 
 
4.3 Contraindications 
 
History of an anaphylactic (i.e. life-threatening) reaction to any of the constituents or trace residues (egg 
and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium deoxycholate) of this 
vaccine. 
 
Immunisation should be postponed in subjects with a severe febrile illness or acute infection. 
 
4.4 Special warnings and precautions for use 
 
The vaccine can only be expected to protect against influenza caused by A/California/07/2009 (H1N1)v-
like strains. 
 
Caution is needed when administering this vaccine to persons with a known hypersensitivity (other than 
anaphylactic reaction) to the active substance, to any of the excipients listed in section 6.1, to thiomersal 



 

4 

and to residues (egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate and sodium 
deoxycholate). 
 
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily 
available in case of a rare anaphylactic event following the administration of the vaccine. 
 
Pandemrix should under no circumstances be administered intravascularly. 
 
There are no data with Pandemrix using the subcutaneous route.  Therefore, healthcare providers need to 
assess the benefits and potential risks of administering the vaccine in individuals with thrombocytopenia 
or any bleeding disorder that would contraindicate intramuscular injection unless the potential benefit 
outweighs the risk of bleedings. 
 
Antibody response in patients with endogenous or iatrogenic immunosuppression may be insufficient. 
 
A protective immune response may not be elicited in all vaccinees (see section 5.1). 
 
There are no safety, immunogenicity or efficacy data to support interchangeability of Pandemrix with 
other (H1N1)v vaccines. 
 
Epidemiological studies relating to Pandemrix in several European countries have indicated an increased 
risk of narcolepsy with or without cataplexy in vaccinated as compared with unvaccinated individuals. In 
children/adolescents (aged up to 20 years), these studies have indicated an additional 1.4 to 8 cases in 
100,000 vaccinated subjects. Available epidemiological data in adults aged over 20 years have indicated 
approximately 1 additional case per 100,000 vaccinated subjects. These data suggest that the excessive 
risk tends to decline with increasing age at vaccination.  
The relationship between Pandemrix and narcolepsy is still under investigation. 
Pandemrix should only be used if the recommended annual seasonal trivalent/quadrivalent influenza 
vaccines are not available and if immunisation against (H1N1)v is considered necessary (see section 4.8). 
 
Paediatric population 
 
There are no safety and immunogenicity data available from clinical studies with Pandemrix (H1N1)v in 
children aged less than 6 months. Vaccination is not recommended in this age group. 
 
In children aged 6 to 35 months (N=51) who received two doses of 0.25 ml (half of the adult dose) with 
an interval of 3 weeks between doses there was an increase in the rates of injection site reactions and 
general symptoms after the second dose (see section 4.8).  In particular rates of fever (axillary 
temperature ≥38°C) increased considerably after the second dose. Therefore, monitoring of temperature 
and measures to lower the fever (such as antipyretic medication as seems clinically necessary) are 
recommended in young children (e.g. up to approximately 6 years of age) after each dose of Pandemrix. 
 
Syncope (fainting) can occur following, or even before, any vaccination especially in adolescents as a 
psychogenic response to the needle injection. This can be accompanied by several neurological signs such 
as transient visual disturbance, paraesthesia and tonic-clonic limb movements during recovery. It is 
important that procedures are in place to avoid injury from faints. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Data obtained on co-administration of Pandemrix (H1N1)v with non-adjuvanted seasonal influenza 
vaccine (Fluarix, a split virion vaccine) in healthy adults aged over 60 years did not suggest any 
significant interference in the immune response to Pandemrix (H1N1)v. The immune response to Fluarix 
was satisfactory. 
Co-administration was not associated with higher rates of local or systemic reactions compared to 
administration of Pandemrix alone.  



 

5 

Therefore the data indicate that Pandemrix may be co-administered with non-adjuvanted seasonal 
influenza vaccines (with injections made into opposite limbs).  
 
Data obtained on the administration of a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) 
three weeks before a dose of Pandemrix (H1N1)v in healthy adults over 60 years of age, did not suggest 
any significant interference in the immune response to Pandemrix (H1N1)v.  Therefore the data indicate 
that Pandemrix may be administered three weeks after the administration of non-adjuvanted seasonal 
influenza vaccines. 
 
In a clinical study where a non-adjuvanted seasonal influenza vaccine (Fluarix, as above) was 
administered 3 weeks after the second dose of Pandemrix (two doses were given 21 days apart), a lower 
immune response to Fluarix was observed as compared to subjects who had not previously received 
Pandemrix.  It is not known whether the observed effects would apply to administration of non-
adjuvanted seasonal influenza vaccine after a single dose of Pandemrix or when longer dose intervals 
have elapsed since administration of Pandemrix.  It is preferable that non-adjuvanted seasonal influenza 
vaccines should be administered before or with the first dose of Pandemrix. 
 
There are no data on co-administration of Pandemrix with other vaccines. 
If co-administration with another vaccine is considered, immunisation should be carried out on separate 
limbs. It should be noted that the adverse reactions may be intensified. 
 
The immunological response may be diminished if the patient is undergoing immunosuppressant 
treatment. 
 
Following influenza vaccination, false-positive serology test results may be obtained by the ELISA 
method for antibody to human immunodeficiency virus-1 (HIV-1), hepatitis C virus and, especially, 
HTLV-1. In such cases, the Western blot method is negative.  These transitory false-positive results may 
be due to IgM production in response to the vaccine. 
 
4.6  Fertility, pregnancy and lactation 
 
Pregnancy 
 
Pandemrix has been administered to women in each trimester of pregnancy. Information on outcomes 
from estimated more than 200,000 women who have been vaccinated during pregnancy is currently 
limited. There was no evidence of an increased risk of adverse outcomes in over 100 pregnancies that 
were followed in a prospective clinical study. 
 
Animal studies with Pandemrix do not indicate reproductive toxicity (see section 5.3). 
 
Data from pregnant women vaccinated with different inactivated non-adjuvanted seasonal vaccines do not 
suggest malformations or fetal or neonatal toxicity. 
 
Breast-feeding 
 
Pandemrix may be administered in lactating women. 
 
Fertility 
 
No fertility data are available. 
 
4.7 Effects on ability to drive and use machines 
 
Some of the effects mentioned under section 4.8 “Undesirable Effects” may affect the ability to drive or 
use machines. 
 



 

6 

4.8 Undesirable effects 
 
Summary of the safety profile 
 
Clinical studies have evaluated the incidence of adverse reactions in more than 1,000 subjects 18 years 
old and above who received Pandemrix (H1N1). 
 
In adults 18 to 60 years of age, the most frequently reported adverse reactions after vaccination were 
injection site pain (87.8%), fatigue (32.9%), headache (28.1%), arthralgia (17.9%), myalgia (30.0%), 
shivering (19.4%), injection site swelling (11.5%) and sweating (11.3%). 
 
In subjects > 60 years of age, the most frequently reported adverse reactions after vaccination were 
injection site pain (59.0%), myalgia (20.6%), fatigue (17.9%), headache (17.6%) and arthralgia (14.3%). 
 
Tabulated list of adverse reactions 
 
Adverse reactions reported are listed per dose according to the following frequency: 
 
Very common (≥1/10) 
Common (≥1/100 to <1/10) 
Uncommon (≥1/1,000 to <1/100) 
Rare (≥1/10,000 to <1/1,000) 
Very rare (<1/10,000) 
 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. 
 
System Organ Class Frequency Adverse reactions 
Clinical trials 
Blood and lymphatic system 
disorders 

Uncommon Lymphadenopathy 

Psychiatric disorders Uncommon Insomnia 
Nervous system disorders 
 

Very common Headache 
Uncommon Paraesthesia, dizziness 

Gastrointestinal disorders 
 

Common Gastrointestinal symptoms (such as 
diarrhoea, vomiting, abdominal pain, 
nausea) 

Skin and subcutaneous tissue 
disorders 

Very common Sweating increased 
Uncommon Pruritus, rash 

Musculoskeletal and 
connective tissue disorders 

Very common Arthralgia, myalgia 

General disorders and 
administration site conditions 
 

Very common Swelling and pain at the injection site, 
fatigue, shivering 

Common Redness and pruritus at the injection site, 
fever 

Uncommon induration and warmth at the injection site, 
influenza like illness, malaise 

Post-marketing experience with Pandemrix (H1N1)v 
Immune system disorders 
 

 Anaphylaxis, allergic reactions 
 

Nervous system disorders  Febrile convulsions 
Very rare1 Narcolepsywith or without cataplexy (see 

section 4.4) 
 Somnolence2 

Skin and subcutaneous tissue 
disorders 

 Angioedema, generalised skin reactions, 
urticaria 



 

7 

General disorders and 
administration site conditions 

 Injection site reactions (such as 
inflammation, mass, ecchymosis) 

Post-marketing experience with trivalent seasonal influenza vaccines 
Blood and lymphatic system 
disorders 

Rare 
 

Transient thrombocytopenia 

Nervous system disorders 
 

Rare 
 

Neuralgia 

Very rare Neurological disorders, such as 
encephalomyelitis, neuritis and Guillain 
Barré syndrome 

Vascular disorders Very rare Vasculitis with transient renal involvement 
1frequency based on estimated attributable risk from epidemiological studies in several European 
countries (see section 4.4) 
 2Reported in patients with narcolepsy and as a temporary event following vaccination 
 
In clinical studies that evaluated reactogenicity in adults aged 18 years and above who received two 0.5 
ml doses of Pandemrix (H1N1)v, higher rates of general solicited symptoms (such as fatigue, headache, 
arthralgia, myalgia, shivering, sweating and fever) were observed after the second dose compared to the 
first dose. 
 
Paediatric population 
 
Children aged 10-17 years 
 
In clinical studies that evaluated the reactogenicity in children 10 to 17 years of age who received either 
two 0.5 ml doses (adult dose) or two 0.25 ml doses (half adult dose) (21 days apart) of Pandemrix 
(H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table: 
 
Adverse reactions 10-17 years 

Half adult dose Adult dose 
Post dose 1 

N=118 
Post dose 2 

N=117 
Post dose 1 

N=98 
Post dose 2 

N=93 
Pain 73.7% 68.4% 92.9% 96.8% 
Redness 22.9% 31.6% 21.4% 28.0% 
Swelling 30.5% 25.6% 41.8% 53.8% 
Shivering 20.3% 16.2% 14.3% 26.9% 
Sweating 7.6% 6.8% 5.1% 7.5% 
Fever >38°C 1.7% 5.1% 3.1% 9.7% 
Fever >39°C 1.7% 1.7% 0.0% 1.1% 
Arthralgia 9.3% 15.4% 26.5% 34.4% 
Myalgia 22.0% 23.1% 34.7% 47.3% 
Fatigue 28.0% 27.4% 40.8% 51.6% 
Gastrointestinal 11.0% 12.0% 6.1% 6.5% 
Headache 35.6% 35.0% 41.8% 53.8% 
  
Children aged 3-9 years 
 
In clinical studies that evaluated reactogenicity in children 3 to 5 and 6 to 9 years of age who received 
either two 0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix 
(H1N1)v, the per-dose frequency of the following adverse reactions was as shown in the table: 
 
Adverse reactions 3-5 years 6-9 years 

Half adult dose Adult dose Half adult dose Adult dose 
Post 

dose 1 
Post 

dose 2 
Post 

dose 1 
Post 

dose 2 
Post 

dose 1 
Post 

dose 2 
Post 

dose 1 
Post 

dose 2 



 

8 

N=60 N=56 N=53 N=52 N=65 N=63 N=57 N=57 
Pain 60.0% 55.4% 75.5% 84.6% 63.1% 65.1% 94.7% 96.5% 
Redness 26.7% 41.1% 28.3% 34.6% 23.1% 33.3% 24.6% 33.3% 
Swelling 21.7% 28.6% 34.0% 30.8% 23.1% 25.4% 28.1% 45.6% 
Shivering 13.3% 7.1% 3.8% 9.6% 10.8% 6.3% 7.0% 22.8% 
Sweating 10.0% 5.4% 1.9% 7.7% 6.2% 7.9% 1.8% 7.0% 
Fever >38°C 10.0% 14.3% 5.7% 32.6% 4.6% 6.4% 1.8% 12.3% 
Fever >39°C 1.7% 5.4% 0.0% 3.8% 0.0% 3.2% 0.0% 1.8% 
Diarrhoea 5.0% 5.4% 1.9% 5.8% NA NA NA NA 
Drowsiness 23.3% 17.9% 15.1% 28.8% NA NA NA NA 
Irritability 20.0% 26.8% 18.9% 26.9% NA NA NA NA 
Loss of appetite 20.0% 17.9% 15.1% 32.7% NA NA NA NA 
Arthralgia NA NA NA NA 15.4% 14.3% 14.0% 22.8% 
Myalgia NA NA NA NA 16.9% 17.5% 22.8% 28.1% 
Fatigue NA NA NA NA 27.7% 20.6% 35.1% 49.1% 
Gastrointestinal NA NA NA NA 13.8% 7.9% 15.8% 14.0% 
Headache NA NA NA NA 21.5% 20.6% 42.1% 45.6% 
NA= not available 
 
Children aged 6-35 months 
 
In a clinical study that evaluated reactogenicity in children aged 6 to 35 months who received either two 
0.25 ml doses (half adult dose) or two 0.5 ml doses (adult dose) (21 days apart) of Pandemrix (H1N1)v 
there was an increase in injection site reactions and general symptoms after the second dose compared to 
the first dose particularly in rates of axillary fever (>38°C).  The per-dose frequency of the following 
adverse reactions was as shown in the table: 
 
Adverse reactions Half adult dose Adult dose 

Post dose 1 
N=104 

Post dose 2 
N=104 

Post dose 1 
N=53 

Post dose 2 
N=52 

Pain 35.6% 41.3% 58.5% 51.9% 
Redness 18.3% 32.7% 32.1% 44.2% 
Swelling 11.5% 28.8% 20.8% 32.7% 
Fever (>38°C) 
axillary 

6.8% 41.4% 7.6% 46.1% 

Fever (>39°C) 
axillary 

1.0% 2.9% 1.9% 17.3% 

Drowsiness  16.3% 33.7% 20.8% 42.3% 
Irritability 26.9% 43.3% 22.6% 51.9% 
Loss of appetite 17.3% 39.4% 20.8% 50.0% 
 
This medicinal product contains thiomersal (an organomercuric compound) as a preservative and 
therefore, it is possible that sensitisation reactions may occur (see section 4.4). 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows 
continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are 
asked to report any suspected adverse reactions via the national reporting system listed in Appendix V. 
 
4.9 Overdose 
 
No case of overdose has been reported. 
 
 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

9 

5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Influenza vaccines, ATC Code: J07BB02. 
 
Pharmacodynamic effects 
 
Immune response to Pandemrix (H1N1)v 
 
Adults aged 18-60 years 
 
Two clinical studies evaluated the immunogenicity of Pandemrix in healthy subjects aged 18-60 years.  
All subjects received two doses of 0.5 ml 21 days apart, except in study D-Pan H1N1-008, in which half 
of the subjects received only one dose of 0.5 ml. The anti-HA antibody responses were as follows: 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 

 D-Pan H1N1-007 D-Pan H1N1-008 
21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose 
Total 

enrolled 
subjects 
N=60 
[95% 
CI] 

Sero-
negative 
subjects  
prior to 

vaccination 
N=37 

[95% CI] 

Total 
enrolled 
subjects 
N=59 
[95% 
CI] 

Sero-
negative 
subjects  
prior to 

vaccination 
N=37 

[95% CI] 

Total 
enrolled 
subjects 
N=120 
[95% 
CI] 

Sero-
negative 
subjects  
prior to 

vaccination 
N=76 

[95% CI] 

Total 
enrolled 
subjects 
N=66 
[95% 
CI] 

Sero-
negative 
subjects  
prior to 

vaccination 
N=42 

[95% CI] 
Sero-
protection 
rate1 

100% 
[94.0; 
100] 

100% 
[90.5;100] 

100% 
[93.9; 
100] 

100% 
[90.5;100] 

97.5% 
[92.9; 
99.5] 

96.1% 
[88.9;99.2] 

100% 
[94.6; 
100] 

100% 
[91.6;100] 

Sero-
conversio
n rate2 

98.3% 
[91.1; 
100] 

100% 
[90.5; 
100] 

98.3% 
[90.9; 
100] 

100% 
[90.5;100] 

95.0% 
[89.4; 
98.1] 

96.1% 
[88.9;99.2] 

98.5% 
[91.8; 
100] 

100% 
[91.6;100] 

Sero-
conversio
n factor3 

 
38.1 

 
47.0 

 
72.9 

 
113.3 

42.15 
[33.43; 
53.16] 

50.73 
[37.84; 
68.02] 

69.7 
[53.79; 
90.32] 

105.9 
[81.81;137.

08] 
1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
 
Six months after the first dose, the seroprotection rate was as follows: 
 

anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
D-Pan H1N1-007 D-Pan H1N1-008 

Month 6 after 2 doses of 0.5 
ml 

Month 6 after 2 doses of 
0.5 ml 

Month 6 after 1 dose of 0.5 
ml 

 Total 
enrolled 
subjects 
N=59 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=35 

Total 
enrolled 
subjects 
N=67 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=43 

Total enrolled 
subjects 
N=51 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=32 



 

10 

[95% CI] [95% CI] [95% CI] 
Seroprotection 
rate1 

100% 
[93.9;100] 

100% 
[90.0;100] 

97.0% 
[89.6;99.6] 

95.3% 
[84.2;99.4] 

86.3% 
[73.7;94.3] 

78.1% 
[60.0;90.7] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
 
Twelve months after the first dose, the seroprotection rate was as follows: 
 

anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
D-Pan H1N1-007 D-Pan H1N1-008 

Month 12 after 2 doses of 
0.5 ml 

Month 12 after 2 doses of 
0.5 ml 

Month 12 after 1 dose of 0.5 
ml 

 Total 
enrolled 
subjects 
N=59 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=36 

[95% CI] 

Total 
enrolled 
subjects 
N=67 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=43 

 [95% CI] 

Total enrolled 
subjects 
N=52 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=32 

[95% CI] 
Seroprotection 
rate1 

78.0% 
[65.3;87.7] 

66.7% 
[49.8;80.9] 

79.1% 
[67.4;88.1] 

69.8% 
[53.9;82.8] 

65.4% 
[50.9;78.0] 

53.1% 
[34.7;70.9] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
 
In study D-Pan-H1N1-008, the neutralising antibody responses were as follows: 
 
Serum 
neutralising 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 After 2 doses of 0.5 ml After 1 dose of 0.5 ml 
 Day 21 

N=22 
Day 42 
N=22 

Month 6 
N=22 

Day 21 
N=17 

Day 42 
N=17 

Month 6 
N=17 

Vaccine 
Response 
Rate2 

68.2% 
[45.1;86.1] 

90.9% 
[70.8;98.9] 

81.8% 
[59.7;94.8] 

70.6% 
[44.0;89.7] 

64.7% 
[38.3;85.8] 

35.3% 
[14.2;61.7] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Elderly (>60 years) 
 
The anti-HA antibody responses in healthy subjects aged >60 years who received either one or two doses 
of 0.5 ml 21 days apart were as follows: 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
61-70 years 71-80 years 

21 days after 1st dose 21 days after 2nd dose 21 days after 1st dose 21 days after 2nd dose 
Total 

enrolled 
subjects 
N=75 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=43 

[95% CI] 

Total 
enrolled 
subjects 
N=40 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=23 

[95% CI] 

Total 
enrolled 
subjects 
N=40 
[95% 
CI] 

Sero- 
negative 
subjects 
prior to 

vaccination 
N=23 

[95% CI] 

Total 
enrolled 
subjects 
N=24 
[95% 
CI] 

Sero- 
negative 
subjects 
prior to 

vaccinatio
n 

N=15 
[95% CI] 

Sero-
protection 

88.0% 
[78.4; 

81.4% 
[66.6;91.6] 

97.5% 
[86.8; 

95.7% 
[78.1;99.9] 

87.5% 
[73.2; 

82.6% 
[61.2;95.0] 

100% 
[85.8; 

100% 
[78.2;100



 

11 

rate1 94.4] 99.9] 95.8] 100] ] 
Sero-
conversion 
rate2 

80.0% 
[69.2; 
88.4] 

81.4% 
[66.6;91.6] 

95.0% 
[83.1; 
99.4] 

95.7% 
[78.1;99.9] 

77.5% 
[61.5; 
89.2] 

82.6% 
[61.2;95.0] 

91.7% 
[73.0; 
99.0] 

100% 
[78.2;100

] 
Sero-
conversion 
factor3 

13.5 
[10.3; 
17.7] 

20.3 
[13.94; 
28.78] 

37.45 
[25.29; 
55.46] 

62.06 
[42.62; 
90.37] 

13.5 
[8.6; 
21.1] 

20.67 
[11.58; 
36.88] 

28.95 
[17.02; 
49.23] 

50.82 
[32.97; 
78.35] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;  
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
 
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like 

>80 years 
21 days after 1st dose 21 days after 2nd dose 

Total enrolled 
subjects 

N=5 
[95% CI] 

Seronegative 
subjects prior to 

vaccination 
N=3 

[95% CI] 

Total enrolled 
subjects 

N=3 
[95% CI] 

Seronegative 
subjects prior to 

vaccination 
N=1 

[95% CI] 
Seroprotection 
rate1 

80.0% 
[28.4;99.5] 

66.7% 
[9.4;99.2] 

100% 
[29.2;100] 

100% 
[2.5;100] 

Seroconversion 
rate2 

80.0% 
[28.4;99.5] 

66.7% 
[9.4;99.2] 

100% 
[29.2;100] 

100% 
[2.5;100] 

Seroconversion 
factor3 

18.4 
[4.3;78.1] 

17.95 
[0.55;582.25] 

25.49 
[0.99;654.60] 

64.0 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40;  
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
 
Six months after the first dose, the seroprotection rate was as follows: 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
61-70 years 71-80 years 

Month 6 after 2 doses of 
0.5 ml 

Month 6 after 1 dose 
of 0.5 ml 

Month 6 after 2 doses 
of 0.5 ml 

Month 6 after 1 dose 
of 0.5 ml 

 Total 
enrolled 
subjects 
N=41 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=23 

[95% CI] 

Total 
enrolled 
subjects 
N=33 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=19 

[95% CI] 

Total 
enrolled 
subjects 
N=24 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=15 

[95% CI] 

Total 
enrolled 
subjects 
N=15 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 
vaccina-

tion 
N=7 

[95% CI] 
Seropro- 
tection rate1 

92.7% 
[80.1; 
98.5] 

91.3% 
[72.0; 
98.9] 

51.5% 
[33.5; 
69.2] 

31.6% 
[12.6; 
56.6] 

83.3% 
[62.6; 
95.3] 

73.3% 
[44.9; 
92.2] 

66.7% 
[38.4; 
88.2] 

28.6% 
[3.7; 
71.0] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
 
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like 



 

12 

>80 years 
Month 6 after 2 doses of 0.5 ml Month 6 after 1 dose of 

0.5 ml 
Total enrolled 

subjects 
N=3 

[95% CI] 

Seronegative subjects prior to 
vaccination 

N=1 
[95% CI] 

Total enrolled subjects2 
N=2 

[95% CI] 

Seroprotection 
rate1 

100% 
[29.2;100] 

100% 
[2.5;100] 

50.0% 
[1.3;98.7] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
2all subjects seronegative prior to vaccination 
 
Twelve months after the first dose, the seroprotection rate was as follows: 
 

anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
61-70 years 71-80 years 

Month 12 after 2 doses 
of 0.5 ml 

Month 12 after 1 dose 
of 0.5 ml 

Month 12 after 2 doses 
of 0.5 ml 

Month 12 after 1 
dose of 0.5 ml 

 Total 
enrolled 
subjects 
N=40 

[95% CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=23 

[95% CI] 

Total 
enrolled 
subjects 
N=33 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=19 

 [95% CI] 

Total 
enrolled 
subjects 
N=25 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 

vaccination 
N=16 

[95% CI] 

Total 
enrolled 
subjects 
N=15 
[95% 
CI] 

Sero-
negative 
subjects 
prior to 
vaccina-

tion 
N=7 

[95% CI] 
Seropro- 
tection rate1 

55.0% 
[38.5;70.

7] 

34.8% 
[16.4;57.3] 

39.4% 
[22.9;57

.9] 

21.1% 
[6.1;45.6] 

48.0% 
[27.8;68

.7] 

25.0% 
[7.3;52.4] 

53.3% 
[26.6;78

.7] 

14.3% 
[0.4;57.9] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
 
anti-HA antibody Immune response to A/California/7/2009 (H1N1)v-like 
 >80 years 
 Month 12 after 2 doses of 0.5 ml Month 12 after 1 

dose of 0.5 ml 
 Total enrolled 

subjects 
N=3 

[95% CI] 

Seronegative 
subjects prior to 

vaccination 
N=1 

[95% CI] 

Total enrolled 
subjects2 

N=2 
[95% CI] 

Seroprotection 
rate1 

100% 
[29.2;100] 

100% 
[2.5;100] 

50.0% 
[1.3;98.7] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40 
2all subjects seronegative prior to vaccination 
 
The neutralising antibody responses in subjects >60 years were as follows: 
 
Serum 
neutralising 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 After 2 doses of 0.5 ml After 1 dose of 0.5 ml 
 Day 21 

N=22 
Day 42 
N=22 

Month 6 
N=22 

Day 21 
N=18 

Day 42 
N=18 

Month 6 
N=18 

Vaccine 
Response 

68.2% 
[45.1;86.1] 

86.4% 
[65.1;97.1] 

63.6% 
[40.7;82.8] 

33.3% 
[13.3;59.0] 

27.8% 
[9.7;53.5] 

38.9% 
[17.3;64.3] 



 

13 

Rate2 
1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Paediatric population  
 
Children aged 10-17 years 
 
Two clinical studies evaluated the administration of a half (0.25 ml) dose and a full (0.5 ml) adult dose of 
Pandemrix in healthy children 10 to 17 years of age.  The anti-HA antibody responses 21 days after the 
first and the second dose were as follows: 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
Half dose 

(D-Pan-H1N1-023) 
Full dose 

(D-Pan-H1N1-010) 
Total subjects4 

 [95% CI] 
Seronegative subjects 
prior to vaccination 

 [95% CI] 

Total subjects4 
 [95% CI] 

Seronegative subjects 
prior to vaccination 

 [95% CI] 
Post dose 

1 
N=54 

Post 
dose 2 
N=54 

Post dose 
1 

N=37 

Post dose 
2 

N=37 

Post dose 
1 

N=92 

Post dose 
2 

N=88 

Post dose 
1 

N=59 

Post dose 
2 

N=57 
Sero-
protection 
rate1 

98.1% 
[90.1; 
100] 

100% 
[93.4; 
100] 

97.3% 
[85.8; 
99.9] 

100% 
[90.5; 
100] 

100% 
[96.1; 
100] 

100% 
[95.9; 
100] 

100% 
[93.9; 
100] 

100% 
[93.7; 
100] 

Sero-
conversion 
rate2 

96.3% 
[87.3; 
99.5] 

98.1% 
[90.1; 
100] 

97.3% 
[85.8; 
99.9] 

100% 
[90.5; 
100] 

96.7% 
[90.8; 
99.3] 

96.6% 
[90.4; 
99.3] 

100% 
[93.9; 
100] 

100% 
[93.7; 
100] 

Sero-
conversion 
factor3 

48.29 
[35.64; 
65.42] 

107.74 
[76.64; 
151.45] 

67.7 
[49.21; 
93.05 

187.92 
[150.67; 
234.38] 

72.2 
[57.2; 
91.2] 

139.1 
[105.7; 
183.1] 

99.4 
[81.0; 
122.1] 

249.8 
[212.9; 
293.2] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4according to protocol 
 
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100%. 
 
Twelve months after the first dose, the seroprotection rates in the children who had received two half 
(0.25 ml) doses were 90.2% and 100% in those who had received two full (0.5 ml) adult doses. 
 
The neutralising antibody responses were as follows: 
 
Serum 
neutralising 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 Half dose Full dose 
 Post  dose 1 

N=13 
Post dose 2 

N=14 
Month 6 

N=13 
Post dose 1 

N=30 
Post dose 2 

N=29 
Month 12 

N=28 
Vaccine 

Response 
Rate2 

69.2% 
[38.6;90.9] 

100% 
[76.8;100] 

92.3% 
[64.0;99.8] 

86.7% 
[69.3;96.2] 

100% 
[88.1;100] 

89.3% 
[71.8;97.7] 



 

14 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Children aged 3 to 9 years 
 
In two clinical studies in which children aged 3 to 9 years old received two 0.25 ml doses (half adult 
dose) or two 0.5 ml doses (adult dose) of Pandemrix, the anti-HA antibody responses 21 days after the 
first and the second dose were as follows: 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
3-5 years 

Half adult dose 
(D-Pan-H1N1-023) 

Adult dose5 
(D-Pan-H1N1-010) 

Total subjects4 
N=28 

[95% CI] 

Seronegative subjects prior 
to vaccination 

N=26 
[95% CI] 

Total subjects4 
N=51 

[95% CI] 

Post dose 1 Post dose 2 Post dose 1 Post dose 2 Post dose 1 Post dose 2 
Seroprotection 
rate1 

100% 
[87.7;100] 

100% 
[87.7;100] 

100% 
[86.8;100] 

100% 
[86.8;100] 

100% 
[93.0;100] 

100% 
[93.0;100] 

Seroconversion 
rate2 

100% 
[87.7;100] 

100% 
[87.7;100] 

100% 
[86.8;100] 

100% 
[86.8;100] 

100% 
[93.0;100] 

100% 
[93.0;100] 

Seroconversion 
factor3 

33.62 
[26.25;43.05] 

237.68 
[175.28;322.29] 

36.55 
[29.01;46.06] 

277.31 
[223.81; 
343.59] 

49.1 
[41.9;57.6] 

384.9 
[336.4;440.3] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4according to protocol 
5all subjects seronegative prior to vaccination 
 

anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
6-9 years 

Half adult dose 
(D-Pan-H1N1-023) 

Adult dose 
(D-Pan-H1N1-010) 

Total subjects4 
N=30 

[95% CI] 

Seronegative subjects 
prior to vaccination 

N=29 
[95% CI] 

Total subjects4 
N=55 

[95% CI] 

Seronegative 
subjects prior to 

vaccination 
N=48 

[95% CI] 
Post dose 

1 
Post dose 

2 
Post dose 

1 
Post dose 

2 
Post dose 

1 
Post dose 

2 
Post 

dose 1 
Post 

dose 2 
Seroprotection 
rate1 

100% 
[88.4; 
100] 

100% 
[88.4; 
100] 

100% 
[88.1; 
100] 

100% 
[88.1; 
100] 

100% 
[93.5; 
100] 

100% 
[93.5; 
100] 

100% 
[92.6; 
100] 

100% 
[92.6; 
100] 

Seroconversion 
rate2 

100% 
[88.4; 
100] 

100% 
[88.4; 
100] 

100% 
[88.1; 
100] 

100% 
[88.1; 
100] 

100% 
[93.5; 
100] 

100% 
[93.5; 
100] 

100% 
[92.6; 
100 

100% 
[92.6; 
100 

Seroconversion 
factor3 

36.33 
[27.96; 
47.22] 

185.25 
[142.09; 
241.52] 

37.7 
[28.68; 
48.71] 

196.81 
[154.32; 
251.00] 

59.0 
[48.3; 
72.0] 

225.7 
[182.7; 
278.2] 

61.7 
[49.9; 
76.3] 

283.2 
[246.0; 
326.0] 



 

15 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4according to protocol 
 
The Day 180 seroprotection rate in the children who had received two half (0.25 ml) doses was 100% in 
both age groups. Twelve months after the first dose, the seroprotection rate was 85% in both age groups. 
In the children who had received two adult (0.5 ml) doses, the seroprotection rates twelve months after 
the first dose were 100% for children aged 3-5 years and 98.0% for those aged 6-9 years. 
 
The neutralising antibody responses were as follows: 
 

Serum neutrali-sing 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 3-5 years 
 Half adult dose Adult dose 
 Post dose 

1 
N=16 

Post dose 
2 

N=15 

Month 
6 

N=16 

Post dose 
1 

N=32 

Post dose 
2 

N=29 

Month 
12 

N=24 
Vaccine Response Rate2 50.0% 

[24.7; 
75.3] 

100% 
[78.2; 
100] 

100% 
[79.4; 
100] 

81.3% 
[63.6; 
92.8] 

100% 
[88.1; 
100] 

100% 
[85.8; 
100] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 

Serum 
neutralising 

antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 6-9 years 
 Half adult dose Adult dose 
 Post dose 1 

N=14 
Post dose 2 

N=15 
Month 6 

N=15 
Post dose 1 

N=37 
Post dose 2 

N=37 
Month 12 

N=31 
Vaccine 

Response 
Rate2 

71.4% 
[41.9; 
91.6] 

100% 
[78.2; 
100] 

93.3% 
[68.1; 
99.8] 

86.7% 
[69.3; 
96.2] 

100% 
[88.1; 
100] 

96.8% 
[83.3; 
99.1] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Children aged 6-35 months 
 
In a clinical study (D-Pan-H1N1-009) in healthy children 6 months to 35 months of age (stratified in 
ranges from 6 to 11, 12 to 23 and 24-35 months of age) the anti-HA antibody responses 21 days after a 
first and a second half adult dose (i.e. 0.25 ml) or adult dose (i.e. 0.5 ml) of Pandemrix were as follows: 
 

anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
6-11 months 

Half adult dose Adult dose 
Total subjects4 

 [95% CI] 
Seronegative subjects 
prior to vaccination 

 [95% CI] 

Total subjects4 
 [95% CI] 

Seronegative subjects 
prior to vaccination 

 [95% CI] 



 

16 

Post dose 
1 

Post dose 
2 

Post dose 
1 

Post dose 
2 

Post dose 
1 

Post dose 
2 

Post dose 
1 

Post dose 
2 

N=34 
 

N = 32 N=30 
 

N=28 N=15 N=15 N=14 N=14 

Sero- 
protection  
rate1 

100% 
[89.7; 
100] 

100% 
[89.1; 
100] 

100% 
[88.4; 
100] 

100% 
[87.7; 
100] 

100% 
[78.2; 
100] 

100% 
[78.2; 
100] 

100% 
[76.8; 
100] 

100% 
[76.8; 
100] 

Sero- 
conversion  
rate2 

97.1% 
[84.7; 
99.9] 

100% 
[89.1; 
100] 

100% 
[88.4; 
100] 

100% 
[87.7; 
100] 

100% 
[78.2; 
100] 

100% 
[78.2; 
100] 

100% 
[76.8; 
100] 

100% 
[76.8; 
100] 

Sero- 
conversion 
factor3 

48.12 
[34.34; 
67.42] 

276.14 
[164.23; 
455.99] 

64.0 
[52.3; 
78.3] 

441.3 
[365.7; 
532.6] 

46.29 
[38.83; 
59.80] 

370;48 
[217,97; 
629,69] 

49.9 
[40.3; 
61.9] 

452.4 
[322.4; 
634.6] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4according to protocol 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
12-23 months 

Half adult dose Adult dose 
Total subjects4 

 [95% CI] 
Seronegative subjects 
prior to vaccination 

 [95% CI] 

Total subjects4 
 [95% CI] 

Seronegative subjects 
prior to vaccination 

 [95% CI] 
Post dose 

1 
Post dose 

2 
Post dose 

1 
Post dose 

2 
Post dose 

1 
Post dose 

2 
Post dose 

1 
Post dose 

2 
N=34 

 
N= 32 N=33 N=31 N=16 N=17 N=15 N=16 

Sero- 
protection 
rate1 

100% 
[89.7; 
100] 

100% 
[89.1; 
100] 

100% 
[89.4; 
100] 

100% 
[88.8; 
100] 

100% 
[79.4; 
100] 

100% 
[80.5; 
100] 

100% 
[78.2; 
100] 

100% 
[79.4; 
100] 

Sero-
conversion 
rate2 

100% 
[89.7; 
100] 

100% 
[89.1; 
100] 

100% 
[89.4; 
100] 

100% 
[88.8; 
100] 

100% 
[79.4; 
100] 

100% 
[80.5; 
100] 

100% 
[78.2; 
100] 

100% 
[79.4; 
100] 

Sero-
conversion 
factor3 

63.37 
[48.13; 
83.43] 

386.45 
[308.54; 
484.02] 

66.7 
[51.4; 
86.7] 

404.8 
[327.8; 
500.0] 

64.06 
[38.55; 
106.44] 

472.16 
[343.74; 
648.57] 

75.3 
[50.3; 
112.5] 

523.2 
[408.5; 
670.1] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4according to protocol 
 
anti-HA 
antibody 

Immune response to A/California/7/2009 (H1N1)v-like 
24-35 months 

Half adult dose4 Adult dose 
Total subjects5 

 [95% CI] 
Total subjects5 

 [95% CI] 
Seronegative subjects prior to 

vaccination 
 [95% CI] 

Post dose 1 Post dose 2 Post dose 1 Post dose 2 Post dose 1 Post dose 2 



 

17 

N=33 
 

N= 33 N=16 N=16 N=12 N=12 

Sero-
protection 
rate1 

100% 
[89.4; 100] 

100% 
[89.4; 100] 

100% 
[79.4;100] 

100% 
[79.4;100] 

100% 
[73.5;100] 

100% 
[73.5;100] 

Sero-
conversion 
rate2 

100% 
[89.4; 100] 

100% 
[89.4; 100] 

93.8 
[69.8;99.8] 

100% 
[79.4;100] 

100% 
[73.5;100] 

100% 
[73.5;100] 

Sero-
conversion 
factor3 

52.97 
[42.08;66.68] 

389.64 
[324.25; 
468.21] 

33.44 
[18.59;60.16] 

189.16 
[83.80; 
427.01] 

55.4 
[39.8;77.2] 

406.4 
[296.2;557.4] 

1 seroprotection rate: proportion of subjects with haemagglutination inhibition (HI) titre ≥1:40; 
2seroconversion rate: proportion of subjects who were either seronegative at pre-vaccination and have a 
protective post-vaccination titre of ≥1:40, or who were seropositive at pre-vaccination and have a 4-fold 
increase in titre;  
3seroconversion factor: ratio of the post-vaccination geometric mean titre (GMT) and the pre-vaccination 
GMT. 
4all subjects seronegative prior to vaccination 
5according to protocol 
 
Twelve months after the first dose, the seroprotection rate was 100% in all age groups and dosage groups. 
 
The clinical relevance of the haemagglutination inhibition (HI) titre ≥1:40 in children is unknown. 
 
The neutralising antibody responses were as follows: 
 
Serum neutrali-sing 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 6-11 months 
 Half dose Adult dose 
 Post dose 

1 
N=28 

Post dose 
2 

N=28 

Month 
12 

N=22 

Post dose 
1 

N=14 

Post dose 
2 

N=14 

Month 
12 

N=10 
Vaccine Response Rate2 57.1% 

[37.2; 
75.5] 

96.4% 
[81.7; 
99.9] 

86.4% 
[65.1; 
97.1] 

57.1% 
[28.9; 
82.3] 

100% 
76.8; 
100] 

100% 
[69.2; 
100] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Serum 
neutrali-sing 
antibody 

Immune response to A/Netherlands/602/9 (H1N1)v-like1 

 12-23 months 
 Half dose Adult dose 
 Post dose 1 

N=14 
Post dose 2 

N=16 
Month 12 

N=13 
Post dose 1 

N=7 
Post dose 2 

N=8 
Month 12 

N=7 
Vaccine 
Response 
Rate2 

57.1% 
[28.9;82.3] 

100% 
[79.4;100] 

92.3% 
[64.0;99.8] 

71.4% 
[29.0;96.3] 

100% 
[63.1;100] 

100% 
[59.0;100] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
Serum Immune response to A/Netherlands/602/9 (H1N1)v-like1 



 

18 

neutrali-
sing 
antibody 
 24-35 months 
 Half dose Adult dose 
 Post dose 1 

N=17 
Post dose 2 

N=17 
Month 12 

N=14 
Post dose 1 

N=8 
Post dose 2 

N=7 
Month 12 

N=5 
Vaccine 
Response 
Rate2 

58.8% 
[32.9;81.6] 

100% 
[80.5;100] 

100% 
[76.8;100] 

62.5% 
[24.5;91.5] 

100% 
[59.0;100] 

100% 
[47.8;100] 

1antigenically similar to A/California/7/2009 (H1N1)v-like 
2percentage of vaccinees who, if initially seronegative reach an antibody titre ≥32 1/DIL after vaccination 
or, if initially seropositive reach an antibody titre ≥ 4-fold the pre-vaccination antibody titre 
 
The European Medicines Agency has deferred the obligation to submit the results of studies with 
Pandemrix in one or more subsets of the paediatric population in the prevention of influenza infection 
(see section 4.2 for information on paediatric use). 
 
Information from non-clinical studies: 
 
The ability to induce protection against homologous and heterologous vaccine strains was assessed non-
clinically using ferret challenge models. 
 
In each experiment, four groups of six ferrets were immunized intramuscularly with an AS03 adjuvanted 
vaccine containing HA derived from H5N1/A/Vietnam/1194/04 (NIBRG-14). Doses of 15, 5, 1.7 or 0.6 
micrograms of HA were tested in the homologous challenge experiment, and doses of 15, 7.5, 3.8 or 1.75 
micrograms of HA were tested in the heterologous challenge experiment. Control groups included ferrets 
immunized with adjuvant alone, non-adjuvanted vaccine (15 micrograms HA) or phosphate buffered 
saline solution. Ferrets were vaccinated on days 0 and 21 and challenged by the intra-tracheal route on 
day 49 with a lethal dose of either H5N1/A/Vietnam/1194/04 or heterologous H5N1/A/Indonesia/5/05. Of 
the animals receiving adjuvanted vaccine, 87% and 96% were protected against the lethal homologous or 
heterologous challenge, respectively. Viral shedding into the upper respiratory tract was also reduced in 
vaccinated animals relative to controls, suggesting a reduced risk of viral transmission. In the 
unadjuvanted control group, as well as in the adjuvant control group, all animals died or had to be 
euthanized as they were moribund, three to four days after the start of challenge. 
 
Additional information is available from the studies conducted with a vaccine similar in composition to 
Pandemrix but containing antigen derived from H5N1 viruses. Please consult the Product Information of 
Pandemic influenza vaccine (H5N1) (split virion, inactivated, adjuvanted). 
 
5.2 Pharmacokinetic properties 
 
Not applicable. 
 
5.3  Preclinical safety data 
 
Non-clinical data obtained with the mock-up vaccine using a H5N1 vaccine strain reveal no special 
hazard for humans based on conventional studies of safety pharmacology, acute and repeated dose 
toxicity, local tolerance, female fertility, embryo-fetal and postnatal toxicity (up to the end of the lactation 
period). 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 



 

19 

Suspension vial: 
Polysorbate 80 
Octoxynol 10 
Thiomersal 
Sodium chloride (NaCl) 
Disodium hydrogen phosphate (Na2HPO4) 
Potassium dihydrogen phosphate (KH2PO4) 
Potassium chloride (KCl) 
Magnesium chloride (MgCl2) 
Water for injections 
 
Emulsion vial: 
Sodium chloride (NaCl) 
Disodium hydrogen phosphate (Na2HPO4) 
Potassium dihydrogen phosphate (KH2PO4) 
Potassium chloride (KCl) 
Water for injections 
 
For adjuvants, see section 2. 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
2 years. 
 
After mixing, the vaccine should be used within 24 hours. Chemical and physical in-use stability has been 
demonstrated for 24 hours at 25°C. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C – 8°C). 
Do not freeze. 
Store in the original package in order to protect from light. 
 
For storage conditions after mixing of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
One pack containing: 
- one pack of 50 vials (type I glass) of 2.5 ml suspension with a stopper (butyl rubber). 
- two packs of 25 vials (type I glass) of 2.5 ml emulsion with a stopper (butyl rubber). 
 
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 
doses of vaccine (5 ml). 
 
6.6 Special precautions for disposal and other handling 
 
Pandemrix consists of two containers:  
Suspension: multidose vial containing the antigen,  
Emulsion: multidose vial containing the adjuvant.  
 
Prior to administration, the two components should be mixed. 



 

20 

 
Instructions for mixing and administration of the vaccine: 
 
1. Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be 

brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and 
inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the 
event of either being observed (including rubber particles from the stopper), discard the vaccine. 

2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by 
means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to 
equip the syringe with a 23-G needle.  However, in the case this needle size would not be available, 
a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside 
down position to facilitate the withdrawal of the full content. 

3. After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed 
vaccine is a whitish to yellowish homogeneous milky liquid emulsion.  In the event of other 
variation being observed, discard the vaccine. 

4. The volume of the Pandemrix vial after mixing is at least 5 ml. The vaccine should be administered 
in accordance with the recommended posology (see section 4.2). 

5. The vial should be shaken prior to each administration and inspected visually for any foreign 
particulate matter and/or abnormal physical appearance.  In the event of either being observed 
(including rubber particles from the stopper), discard the vaccine. 

6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for 
injection and administered intramuscularly. It is recommended to equip the syringe with a needle 
gauge not larger than 23-G. 

7. After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a 
refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored 
in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before 
each withdrawal. 

 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
rue de l'Institut 89 
B-1330 Rixensart, Belgium 
 
 
8.  MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/08/452/001 
 
 
9.  DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 20 May 2008 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu/.



 

21 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 
BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 
 

D.  CONDITIONS OR RESTRICTIONS WITH REGARD TO THE 
SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 
 



 

22 

 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 
 
Name and address of the manufacturer of the biological active substance 
 
GlaxoSmithKline Biologicals 
Branch of SmithKline Beecham Pharma GmbH & Co. KG 
Zirkustraße 40, D-01069 Dresden 
Germany 
 
Name and address of the manufacturer responsible for batch release 
 
GlaxoSmithKline Biologicals S.A. 
89, rue de l'Institut 
B-1330 Rixensart 
Belgium 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to medical prescription. 

 
• Official batch release 
 
In accordance with Article 114 of Directive 2001/83/EC, the official batch release will be undertaken by a 
state laboratory or a laboratory designated for that purpose. 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports 
 
The requirements for submission of periodic safety update reports for this medicinal product are set out in 
the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 
and any subsequent updates published on the European medicines web-portal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
• Risk Management Plan (RMP)  
 
The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed 
RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of 
the RMP. 
 
An updated RMP should be submitted: 
• At the request of the European Medicines Agency; 
• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of an 
important (pharmacovigilance or risk minimisation) milestone being reached. 

 
•  Additional risk minimisation measures  
 



 

23 

The MAH shall agree with Member States to measures facilitating the identification and traceability of 
the A/H1N1 vaccine administered to each patient, in order to minimise medication errors and aid patients 
and health care professionals to report adverse reactions. This may include the provision by the MAH of 
stickers with invented name and batch number with each pack of the vaccine. 
 
The MAH shall agree with Member States on mechanisms allowing patients and health care professionals 
to have continuous access to updated information regarding Pandemrix.   
 
The MAH shall agree with Member States on the provision of a targeted communication to healthcare 
professionals which should address the following: 
• The correct way to prepare the vaccine prior to administration. 
• Adverse events to be prioritised for reporting, i.e. fatal and life-threatening adverse reactions, 

unexpected severe adverse reactions, adverse events of special interest (AESI). 
• The minimal data elements to be transmitted in individual case safety reports in order to facilitate 

the evaluation and the identification of the vaccine administered to each subject, including the 
invented name, the vaccine manufacturer and the batch number. 

• If a specific notification system has been put in place, how to report adverse reactions. 
 
•  Obligation to conduct post-authorisation measures  
 
The MAH shall complete, within the stated timeframe, the below measures: 
 

Description 
 

Due Date 

Conduct non-clinical (including mechanistic) studies in order to 
elucidate the role of the vaccine and its adjuvant on the association 
between Pandemrix and narcolepsy: 
-  Identify T cell signature from narcoleptic patients by deep 

sequencing of total CD4 T cells obtained from narcolepsy patients 
and DQ0602-matched non-vaccinated healthy subjects and, if 
identified, verify if signature is found in CD4 T cells from healthy 
subjects after vaccination with Pandemrix or non-adjuvanted H1N1v 
vaccine. 

- Verify influenza-specificity of hypocretin-specific CD4 T cells from 
narcoleptic patients by complementary assays and verify if cross-
reactive CD4 T cells are found among influenza-specific CD4 T cells 
from healthy subjects after vaccination with Pandemrix or non-
adjuvanted H1N1v vaccine. 

- Phenotypic characterization of hypocretin and influenza-specific T 
cells after stimulation with hypocretin or influenza peptides. 
 

 
 
 
August 2015 
 
 
 
 
 
August 2015 
 
 
 
 
August 2015 

The MAH submitted the data requested above on 5 August 2015 and an opinion was adopted by the 
CHMP on 28 April 2016. Based on the evaluation of the data submitted, the CHMP considers that the 
above post-authorisation measures as reflected above have been fulfilled. Please see details of the 
assessment in the CHMP assessment report EMEA/H/C/000832/II/0079 published on the EMA website. 
 



 

24 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 

25 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



 

26 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PACK CONTAINING 1 PACK OF 50 VIALS OF SUSPENSION AND 2 PACKS OF 25 VIALS 
OF EMULSION 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Pandemrix suspension and emulsion for emulsion for injection. 
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
After mixing, 1 dose (0.5 ml) contains: 
 
Split influenza virus inactivated, containing antigen equivalent to: 
 
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms* 
 
AS03 adjuvant composed of squalene, DL-α-tocopherol and polysorbate 80 
 
* haemagglutinin 
 
 
3. LIST OF EXCIPIENTS 
 
Polysorbate 80 
Octoxynol 10 
Thiomersal 
Sodium chloride (NaCl) 
Disodium hydrogen phosphate (Na2HPO4) 
Potassium dihydrogen phosphate (KH2PO4) 
Potassium chloride (KCl) 
Magnesium chloride (MgCl2) 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension and emulsion for emulsion for injection  
 
50 vials: suspension (antigen) 
50 vials: emulsion (adjuvant) 
The volume after mixing 1 vial of suspension (2.5 ml) with 1 vial of emulsion (2.5 ml) corresponds to 10 
doses of 0.5 ml vaccine 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use 
Shake before use 
Read the package leaflet before use 
 
 



 

27 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 
THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Suspension and emulsion to be mixed before administration 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Dispose of in accordance with local regulations 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart, Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/452/001  
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 



 

28 

 
Justification for not including Braille accepted. 



 

29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PACK OF 50 VIALS OF SUSPENSION (ANTIGEN) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Suspension for emulsion for injection for Pandemrix 
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Split influenza virus, inactivated, containing antigen* equivalent to  
 
3.75 micrograms haemagglutinin/dose 
*Antigen: A/California/07/2009 (H1N1) derived strain used NYMCX-179A 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients:  
Polysorbate 80 
Octoxynol 10 
Thiomersal 
Sodium chloride 
Disodium hydrogen phosphate 
Potassium dihydrogen phosphate 
Potassium chloride 
Magnesium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Antigen suspension for injection 
50 vials: suspension 
2.5 ml per vial.  
After mixing with adjuvant emulsion: 10 doses of 0.5 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use 
Shake before use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 



 

30 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Suspension to be exclusively mixed with adjuvant emulsion before administration 
 
 
8. EXPIRY DATE 
 
EXP 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GSK Biologicals, Rixensart - Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/452/001  
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 



 

31 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
PACK OF 25 VIALS OF EMULSION (ADJUVANT) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Emulsion for emulsion for injection for Pandemrix 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Content: AS03 adjuvant composed of squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) 
and polysorbate 80 (4.86 milligrams) 
 
 
3. LIST OF EXCIPIENTS 
 
Excipients: 
Sodium chloride 
Disodium hydrogen phosphate 
Potassium dihydrogen phosphate 
Potassium chloride 
Water for injections 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Adjuvant emulsion for injection 
25 vials: emulsion 
2.5 ml 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
Intramuscular use 
Shake before use 
Read the package leaflet before use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT OF 

THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
Emulsion to be exclusively mixed with antigen suspension before administration 
 
 
8. EXPIRY DATE 
 
EXP 



 

32 

 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator 
Do not freeze 
Store in the original package in order to protect from light 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS OR 

WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
GSK Biologicals, Rixensart - Belgium 
 
 
12. MARKETING AUTHORISATION NUMBER(S)  
 
EU/1/08/452/001  
 
 
13. BATCH NUMBER 
 
Lot: 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Justification for not including Braille accepted. 



 

33 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
SUSPENSION VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Antigen suspension for Pandemrix 
Influenza vaccine 
A/California/07/2009 (H1N1) derived strain used NYMC X-179A 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
Mix with adjuvant emulsion before use 
 
 
3. EXPIRY DATE 
 
EXP 
After mixing: Use within 24 hours and do not store above 25°C. 
Date and time of mixing: 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.5 ml 
After mixing with adjuvant emulsion: 10 doses of 0.5 ml 
 
 
6. OTHER 
 
Storage (2ºC-8ºC), do not freeze, protect from light 



 

34 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
EMULSION VIAL 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Adjuvant emulsion for Pandemrix 
I.M. 
 
 
2. METHOD OF ADMINISTRATION 
 
Mix into Antigen suspension before use 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.5 ml 
 
 
6. OTHER 
 
Storage (2ºC-8ºC), do not freeze, protect from light 



 

35 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 

36 

 
Package leaflet: Information for the user 

 
Pandemrix suspension and emulsion for emulsion for injection 
Influenza vaccine (H1N1)v (split virion, inactivated, adjuvanted) 

 
This medicine is subject to additional monitoring. This will allow quick identification of new safety 

information. You can help by reporting any side effects you may get. See the end of section 4 for how to 
report side effects. 
 
Read all of this leaflet carefully before you receive this vaccine because it contains important 
information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or nurse. 
- This vaccine has been prescribed for you only.  Do not pass it on to others. 
- If you get any of side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet.  See section 4. 
 
What is in this leaflet:  
1. What Pandemrix is and what it is used for 
2. What you need to know before you receive Pandemrix 
3. How Pandemrix is given 
4. Possible side effects 
5. How to store Pandemrix 
6. Contents of the pack and other information 
 
 
1. What Pandemrix is and what it is used for 
 
What Pandemrix is and what it is used for 
 
Pandemrix is a vaccine to prevent influenza (flu) caused by A(H1N1)v 2009 virus.  
Your doctor will normally recommend a different vaccine (annual trivalent/quadrivalent influenza 
vaccine) instead of Pandemrix, but if the trivalent/quadrivalent vaccines are not available Pandemrix may 
still be an option if you need protection against A(H1N1)v influenza (see Take special care with 
Pandemrix).  
 
How Pandemrix works 
 
When a person is given the vaccine, the immune system (the body’s natural defence system) will produce 
its own protection (antibodies) against the disease. None of the ingredients in the vaccine can cause flu. 
 
 
2. What you need to know before you receive Pandemrix 
 
Pandemrix should not be given: 
 
• if you have previously had a sudden life-threatening allergic reaction to any ingredient of this 

vaccine (listed in section 6) or to any of the substances that may be present in trace amounts as 
follows: egg and chicken protein, ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or 
sodium deoxycholate. Signs of an allergic reaction may include itchy skin rash, shortness of breath 
and swelling of the face or tongue.  

• if you have a severe infection with a high temperature (over 38°C). If this applies to you then your 
vaccination will usually be postponed until you are feeling better. A minor infection such as a cold 
should not be a problem, but your doctor or nurse will advise whether you could still be vaccinated 
with Pandemrix. 



 

37 

 
If you are not sure, talk to your doctor or nurse before having this vaccine. 
 
Warnings and precautions 
 
Talk to your doctor or nurse before you receive Pandemrix: 
 
• if you have had any allergic reaction other than a sudden life-threatening allergic reaction to any  

ingredient contained in this vaccine (listed in section 6), to thiomersal, to egg and chicken protein, 
ovalbumin, formaldehyde, gentamicin sulphate (antibiotic) or to sodium deoxycholate. . 

• if you are having a blood test to look for evidence of infection with certain viruses. In the first few 
weeks after vaccination with Pandemrix the results of these tests may not be correct. Tell the doctor 
requesting these tests that you have recently been given Pandemrix. 

• if you have a bleeding problem or bruise easily. 
 
In any of these cases, TELL YOUR DOCTOR OR NURSE, as vaccination may not be recommended, or 
may need to be delayed. 
 
Excessive sleepiness during the day, often at the wrong times (a long-term condition called narcolepsy), 
has been reported very rarely after vaccination with Pandemrix in several European countries. Narcolepsy 
can occur with or without sudden muscle weakness that can cause falls (a condition called cataplexy). 
 
Children and adolescents 
 
If your child receives the vaccine, you should be aware that the side effects may be more intense after the 
second dose, especially temperature over 38°C. Therefore monitoring of temperature and measures to 
lower the temperature (such as giving paracetamol or other medicines that lower fever) after each dose 
are recommended.  
 
Fainting can occur (mostly in adolescents) following, or even before, any needle injection. Therefore tell 
the doctor or nurse if you fainted with a previous injection. 
 
Other medicines and Pandemrix 
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines or have 
recently received any other vaccine. 
 
Pandemrix can be given at the same time as seasonal influenza vaccines that do not contain an adjuvant.   
 
Persons who have received a seasonal influenza vaccine that does not contain an adjuvant may receive 
Pandemrix after an interval of at least three weeks. 
 
There is  no information on administration of Pandemrix with other vaccines.  However, if this cannot be 
avoided, the vaccines should be injected into separate limbs.  In such cases, you should be aware that the 
side effects may be more intense.  
 
Pregnancy and breast-feeding 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your 
doctor for advice before you receive this vaccine. 
 
Driving and using machines 
Some effects mentioned under section 4. “Possible side effects” may affect the ability to drive or use 
machines. 
 
Pandemrix contains thiomersal 
Pandemrix contains thiomersal as a preservative and it is possible that you may experience an allergic 
reaction. Tell your doctor if you have any known allergies. 



 

38 

 
Pandemrix contains sodium and potassium 
This medicinal product contains less than 1 mmol sodium (23 mg) and less than 1 mmol of potassium (39 
mg) per dose, i.e. essentially sodium- and potassium-free. 
 
 
3. How Pandemrix is given 
 
Your doctor or nurse will administer the vaccine in accordance with official recommendations. 
 
Adults, including the elderly 
A dose (0.5 ml) of the vaccine will be given. 
Clinical data suggest that a single dose may be sufficient. 
If a second dose is administered there should be an interval of at least three weeks between the first and 
second dose. 
 
Use in children and adolescents 
 
Children from the age of 10 years onwards 
A dose (0.5 ml) of the vaccine will be given. 
Clinical data suggest that a single dose may be sufficient. 
If a second dose is administered there should be an interval of at least three weeks between the first and 
second dose. 
 
Children from 6 months to 9 years of age 
A dose (0.25 ml) of the vaccine will be given.  
If a second dose of 0.25 ml is given this will be administered at least three weeks after the first dose.  
 
Children aged less than 6 months of age 
Vaccination is currently not recommended in this age group. 
 
The vaccine will be injected into a muscle (usually in the upper arm).  
 
If you have any further questions on the use of this vaccine, ask your doctor or nurse. 
 
 
4. Possible side effects 

 
Like all medicines, this vaccine can cause side effects, although not everybody gets them. 
 
Allergic reactions: 
 
Allergic reactions may occur following vaccination, in rare cases leading to shock.  Doctors are aware of 
this possibility and have emergency treatment available for use in such cases. 
 
Other side effects: 
 
The side effects listed below have occurred with Pandemrix in clinical studies in adults, including the 
elderly.   
 
Very common: may affect more than 1 in 10 people  
• Headache 
• Tiredness 
• Pain and swelling at the injection site 
• Shivering 
• Increased sweating 



 

39 

• Aching muscles, joint pain 
 
Common: may affect up to 1 in 10 people 
• Redness and itching at the injection site 
• Fever 
• Feeling sick, diarrhoea, vomiting, stomach pain 
 
Uncommon: may affect up to 1 in 100 people 
• A hard lump and warmth at the injection site 
• Swollen glands in the neck, armpit or groin 
• Tingling or numbness of the hands or feet 
• Sleeplessness 
• Dizziness 
• Itching, rash 
• Generally feeling unwell 
• Flu-like symptoms 
 
These side effects usually disappear within 1-2 days without treatment. If they persist, CONSULT YOUR 
DOCTOR. 
 
Additional side effects in children and adolescents 
 
Children aged 10-17 years 
 
The side effects listed above have also been observed with similar frequencies in clinical studies in 
children 10 to 17 years of age, except for redness at the injection site which was very common and 
sweating which was common. 
 
Children aged 3-9 years 
 
In children 3 to 9 years of age who received two 0.25 ml doses of Pandemrix (H1N1) the side effects 
reported were similar to those reported in adults, except for redness at the injection site and 
gastrointestinal symptoms which were very common and shivering and sweating which were common. In 
addition, fever was very common in children aged 3-5 years. Some side effects (including local redness 
and fever) occurred more frequently after the second dose compared to the first dose. 
 
Children aged 6-35 months 
 
In children aged 6-35 months who received two doses of 0.25 ml of Pandemrix (H1N1), there was an 
increase in reports of pain, redness and swelling at the injection site as well as fever (>38°C), drowsiness, 
irritability and loss of appetite after the second dose compared to the first dose.  All these side effects 
were reported very commonly after each dose. 
 
The side effects listed below have happened after Pandemrix (H1N1)v came on the market: 
 
• Allergic reactions leading to a dangerous decrease of blood pressure, which, if untreated, may lead 

to shock. Doctors are aware of this possibility and have emergency treatment available for use in 
such cases. 

• Generalised skin reactions including facial swelling and urticaria (hives) 
• Fits due to fever 
• A long-term condition with excessive daytime sleepiness (narcolepsy), with or without sudden 

weakness (cataplexy), which may lead to falls without loss of consciousness 
• Short-term sleepiness following vaccination 
• Reactions at the injection site such as pain, redness, bruising, swelling and heat (inflammation), 

hard lump (mass) 



 

40 

 
The side effects listed below have occurred in the days or weeks after vaccination with vaccines given 
routinely every year to prevent flu.  They may also happen with Pandemrix. 
 
Rare: may affect up to 1 in 1,000 people 
• Severe stabbing or throbbing pain along one or more nerves 
• Low blood platelet count which can result in bleeding or bruising  
 
Very rare:  may affect up to 1 in 10,000 people 
• Vasculitis (inflammation of the blood vessels which can cause skin rashes, joint pain and kidney 

problems) 
• Neurological disorders such as encephalomyelitis (inflammation of the central nervous system), 

neuritis (inflammation of nerves) and a type of paralysis known a Guillain-Barré Syndrome 
 
Reporting of side effects 
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system listed in 
Appendix V. By reporting side effects you can help provide more information on the safety of this 
medicine. 
 
 
5. How to store Pandemrix 
 
Keep this vaccine out of the sight and reach of children. 
 
Before the vaccine is mixed: 
Do not use the suspension and the emulsion after the expiry date which is stated on the carton.  The 
expiry date refers to the last day of that month. 
 
Store in a refrigerator (2°C - 8°C).  
Store in the original package in order to protect from light. 
Do not freeze.   
 
After the vaccine is mixed: 
After mixing, use the vaccine within 24 hours and do not store above 25°C. 
 
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw 
away medicines you no longer use.  These measures will help protect the environment. 
 
 
6. Contents of the pack and other information 

 
What Pandemrix contains 
 
• Active substance: 

Split influenza virus, inactivated, containing antigen* equivalent to: 
 

 A/California/07/2009 (H1N1) derived strain used NYMC X-179A 3.75 micrograms** per 0.5 ml 
dose 

 
*propagated in eggs 
**expressed in microgram haemagglutinin 
 

• Adjuvant: 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 

41 

The vaccine contains an ‘adjuvant’ AS03 to stimulate a better response.  This adjuvant contains 
squalene (10.69 milligrams), DL-α-tocopherol (11.86 milligrams) and polysorbate 80 (4.86 
milligrams).  

 
• Other ingredients:  

The other ingredients are: polysorbate 80, octoxynol 10, thiomersal, sodium chloride, disodium 
hydrogen phosphate, potassium dihydrogen phosphate, potassium chloride, magnesium chloride, 
water for injections 

 
What Pandemrix looks like and contents of the pack 
 
Suspension and emulsion for emulsion for injection. 
The suspension is a colourless light opalescent liquid.  
The emulsion is a whitish to yellowish homogeneous milky liquid. 
 
Prior to administration, the two components should be mixed.  The mixed vaccine is a whitish to 
yellowish homogeneous milky liquid emulsion. 
 
One pack of Pandemrix consists of:  
• one pack containing 50 vials of 2.5 ml suspension (antigen) 
• two packs containing 25 vials of 2.5 ml emulsion (adjuvant) 
 
Marketing Authorisation Holder and Manufacturer 
 
GlaxoSmithKline Biologicals s.a. 
Rue de l’Institut 89 
B-1330 Rixensart 
Belgium 
 
For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder: 
 
België/Belgique/Belgien 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 
 

Lietuva 
GlaxoSmithKline Lietuva UAB 
Tel: +370 5 264 90 00 
info.lt@gsk.com 

 
България 
ГлаксоСмитКлайн ЕООД 
Тел. + 359 2 953 10 34 
 

 
Luxembourg/Luxemburg 
GlaxoSmithKline Pharmaceuticals s.a./n.v. 
Tél/Tel: + 32 10 85 52 00 

Česká republika 
GlaxoSmithKline s.r.o. 
Tel: + 420 2 22 00 11 11 
cz.info@gsk.com 
 

Magyarország 
GlaxoSmithKline Kft. 
Tel.: + 36-1-2255300 
 

Danmark 
GlaxoSmithKline Pharma A/S 
Tlf: + 45 36 35 91 00 
dk-info@gsk.com 
 

Malta 
GlaxoSmithKline (Malta) Ltd 
Tel: + 356 21 238131 
 

Deutschland 
GlaxoSmithKline GmbH & Co. KG 
Tel: + 49 (0)89 360448701 
produkt.info@gsk.com 
 

Nederland 
GlaxoSmithKline BV 
Tel: + 31 (0)30 69 38 100 
nlinfo@gsk.com 

mailto:dk-info@gsk.com


 

42 

Eesti 
GlaxoSmithKline Eesti OÜ  
Tel: +372 667 6900 
estonia@gsk.com 
 

Norge 
GlaxoSmithKline AS 
Tlf: + 47 22 70 20 00 
firmapost@gsk.no 
 

Ελλάδα 
GlaxoSmithKline A.E.B.E 
Tηλ: + 30 210 68 82 100 
 

Österreich 
GlaxoSmithKline Pharma GmbH. 
Tel: + 43 1 970 75-0 
at.info@gsk.com  
 

España 
GlaxoSmithKline, S.A. 
Tel: + 34 902 202 700 
es-ci@gsk.com  
 

Polska 
GSK Services Sp. z o.o  
Tel.: + 48 (22) 576 9000 
 

France 
Laboratoire GlaxoSmithKline 
Tél: + 33 (0) 1 39 17 84 44 
diam@gsk.com 
 
Hrvatska 
GlaxoSmithKline d.o.o. 
Tel.: + 385 (0)1 6051999 
 

Portugal 
GlaxoSmithKline - Produtos Farmacêuticos, Lda. 
Tel: + 351 21 412 95 00 
FI.PT@gsk.com 
 
România 
GlaxoSmithKline (GSK) SRL 
Tel: +40 (0)21 3028 208 
 

Ireland 
GlaxoSmithKline (Ireland) Ltd 
Tel: + 353 (0)1 495 5000 
 

Slovenija 
GlaxoSmithKline d.o.o. 
Tel: + 386 (0) 1 280 25 00 
medical.x.si@gsk.com 
 
 

Ísland 
GlaxoSmithKline ehf. 
Sími: +354 530 3700 
 

Slovenská republika 
GlaxoSmithKline Slovakia s.r.o. 
Tel: + 421 (0)2 48 26 11 11 
recepcia.sk@gsk.com 

 
Italia 
GlaxoSmithKline S.p.A. 
Tel:+ 39 04 59 21 81 11 
 

 
Suomi/Finland 
GlaxoSmithKline Oy 
Puh/Tel: + 358 10 30 30 30 
Finland.tuoteinfo@gsk.com 

 
Κύπρος 
GlaxoSmithKline (Cyprus) Ltd 
Τηλ: + 357 22 39 70 00 
gskcyprus@gsk.com 
 

  
Sverige 
GlaxoSmithKline AB 
Tel: + 46 (0)8 638 93 00 
info.produkt@gsk.com 
 

Latvija 
GlaxoSmithKline Latvia SIA 
Tel: + 371 67312687 
lv-epasts@gsk.com 
 

United Kingdom 
GlaxoSmithKline UK 
Tel: + 44 (0)808 100 9997 
customercontactuk@gsk.com 
 

This leaflet was last revised in {MM/YYYY}. 
 
Other sources of information 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 

http://www.ema.europa.eu/


 

43 

 
--------------------------------------------------------------------------------------------------------------------- 
 
The following information is intended for healthcare professionals only: 
 
Pandemrix consists of two containers:  
Suspension: multidose vial containing the antigen,  
Emulsion: multidose vial containing the adjuvant.  
 
Prior to administration, the two components should be mixed. 
 
Instructions for mixing and administration of the vaccine: 
 
1. Before mixing the two components, the emulsion (adjuvant) and suspension (antigen) should be 

brought to room temperature (allow a minimum of 15 minutes); each vial should be shaken and 
inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the 
event of either being observed (including rubber particles from the stopper), discard the vaccine. 

2. The vaccine is mixed by withdrawing the entire contents of the vial containing the adjuvant by 
means of a 5 ml syringe and by adding it to the vial containing the antigen. It is recommended to 
equip the syringe with a 23-G needle.  However, in the case this needle size would not be available, 
a 21-G needle might be used. The vial containing the adjuvant should be maintained in upside 
down position to facilitate the withdrawal of the full content. 

3. After the addition of the adjuvant to the antigen, the mixture should be well shaken. The mixed 
vaccine is a whitish to yellowish homogeneous milky liquid emulsion.  In the event of other 
variation being observed, discard the vaccine. 

4. The volume of the Pandemrix vial after mixing is at least 5 ml. The vaccine should be administered 
in accordance with the recommended posology (see section 3 “How Pandemrix is given”). 

5. The vial should be shaken prior to each administration and inspected visually for any foreign 
particulate matter and/or abnormal physical appearance.  In the event of either being observed 
(including rubber particles from the stopper), discard the vaccine. 

6. Each vaccine dose of 0.5 ml (full dose) or 0.25 ml (half dose) is withdrawn into a 1 ml syringe for 
injection and administered intramuscularly. It is recommended to equip the syringe with a needle 
gauge not larger than 23-G. 

7. After mixing, use the vaccine within 24 hours. The mixed vaccine can either be stored in a 
refrigerator (2°C - 8°C) or at room temperature not exceeding 25°C. If the mixed vaccine is stored 
in a refrigerator, it should be brought to room temperature (allow a minimum of 15 minutes) before 
each withdrawal. 

 
The vaccine should not be administered intravascularly. 
 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 


	SUMMARY OF PRODUCT CHARACTERISTICS
	MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET