Prevenar Special Use-result Surveillance in Japan (Regulatory PostMarketing Commitment Plan)

Study Overview
=================
Brief Summary
-----------------
This surveillance aims to figure out 1) use-results, 2) occurrence of adverse events, and 3) factors affecting safety in terms of the safety in infants starting to receive Prevenar at the age of more than 2 and less than 7 months in routine medical practice. This surveillance will specifically focus on the occurrence of the following: Local reactions at the injection site Systemic reactions for each concomitant vaccine (especially fever more than 39C°)

Detailed Description
-----------------
This surveillance will be conducted using a continuous surveillance system, in which each physician enrolls patients who meet the enrollment criteria continuously until the contract sample size is reached.

Official Title
-----------------
Prevenar Special Use-result Surveillance (Multi-center, Prospective Observational Safety Surveillance For Prevenar In Japan)

Conditions
-----------------
Pneumococcal Vaccine, Streptococcus Pneumoniae

Intervention / Treatment
-----------------
* Biological: 7-valent vaccine injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infants at the age of more than 2 and less than 7 months Infants who have been vaccinated with Prevenar for the first time Infants expected to complete four vaccinations with Prevenar Exclusion Criteria: Vaccination with Prevenar must not be given to any of the following; History of evident anaphylactic reaction to any component of Prevenar or diphtheria toxoid Evident pyrexia Evident serious acute disease Any other infants or children ineligible for vaccination

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 2 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 7-valent vaccine injection<br>Infants starting to receive Prevenar at the age of more than 2 and less than 7 months | Biological: 7-valent vaccine injection<br>* For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.<br>* Other names: Prevenar, 7vPnC;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Reactions | An adverse reaction was any untoward medical occurrence which was considered to be related to Prevenar™ (7-valent) in a participant who received Prevenar™ (7-valent). Relatedness to Prevenar™ (7-valent) was assessed by the sponsor (Pfizer Japan Inc.). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events | A serious adverse event was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. | 28 days | 
| Number of Participants With Injection Site Reactions | Injection site reactions (erythema, induration, tenderness, and warmth) were defined by preferred terms of MedDRA/J version 16.0 as follows: erythema for injection site erythema; induration for injection site erythema and injection site swelling; tenderness for injection site pain; and warmth for injection site warmth. | 28 days | 
| Number of Participants With Systemic Reactions (Pyrexia of Over 39C°) by Pattern of Concomitant Vaccination | Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) of over 39C° at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV). | 28 days | 
| Number of Participants With Systemic Reactions (Pyrexia) by Pattern of Concomitant Vaccination | Number of participants with pyrexia (MedDRA/J version 16.0 preferred terms) at each vaccination time (first to fourth) was counted by each pattern of concomitant vaccination. The concomitant vaccines (CVs) used in this survey were; vaccines against Haemophilus influenzae type b (Hib), diphtheria and tetanus toxoids and pertussis (DPT), measles and rubella (MR), influenza (Flu), bacille Calmette-Guérin (BCG), vesicular stomatitis Indiana virus (VSV), Mumps, Hepatitis B (HB); and oral polio vaccine (OPV) and inactivated polio vaccine (IPV). | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pneumococcal Vaccine, Prevenar, 7-valent, Special Use-result surveillance