Evaluation of Immunogenicity and Safety of a Booster Dose of Infanrix Hexa™ in Healthy Infants Born to Mothers Vaccinated With Boostrix™ During Pregnancy or Immediately Post-delivery
Condition: Diphtheria; Hepatitis B; Acellular Pertussis; Haemophilus Influenzae Type b; Tetanus; Poliomyelitis; Diphtheria-Tetanus-aPertussis-Hepatitis B-Poliomyelitis-Haemophilus Influenzae Type b Vaccines
MeSH terms: Hepatitis A; Influenza, Human; Hepatitis B; Whooping Cough; Tetanus; Diphtheria; Poliomyelitis; Hepatitis; Tetany
Intervention: Infanrix hexa
Intervention description: All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.
Phase: Phase 4
Study type: Interventional
Primary purpose: Prevention
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 551.0
Sex: All
Minimum age: 9 Months
Maximum age: 19 Months
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Pertussis; Immunogenicity; Poliomyelitis; Tetanus; Hepatitis B; Diptheria

Summary:

      The purpose of this study is to assess the immunogenicity and safety of the Infanrix hexa
      booster dose given at 11-18 months of age to infants who received primary vaccination at 6-14
      weeks. All infants in this booster study were born to pregnant women who participated in the
      study 116945 [DTPA (BOOSTRIX)-047] and having received the full primary vaccination series as
      per protocol requirement in study 201330 [DTPA (BOOSTRIX)-048.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Subjects' parent(s)/Legally acceptable representatives (LAR(s)) who, in the opinion of
             the investigator, can and will comply, with the requirements of the protocol (e.g.
             completion of the diary cards, return for follow-up visits).

          -  Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to
             performing any study specific procedure.

          -  A male or female child 9 months of age at the time of enrolment.

          -  Healthy subjects as established by medical history and clinical examination before
             entering into the study.

          -  Subjects born to mothers who were vaccinated in 116945 [DTPA (BOOSTRIX)-047] study and
             having completed their primary vaccination series as per protocol requirement in study
             201330 [DTPA (BOOSTRIX)-048 PRI].

        Exclusion Criteria:

          -  Child in care

          -  Concurrently participating in another clinical study, within three months prior to the
             booster vaccine dose and at any time during the present booster study, in which the
             subject has been or will be exposed to an investigational or a non-investigational
             vaccine/product (pharmaceutical product or device).

          -  Chronic administration (defined as more than 14 days in total) of immunosuppressants
             or other immune-modifying drugs during the period within six months prior to the
             booster vaccine dose. For corticosteroids, this will mean prednisone ≥0.5mg/kg/day, or
             equivalent. Inhaled and topical steroids are allowed.

          -  Administration of long-acting immune-modifying drugs at any time during the study
             period (e.g. infliximab).

          -  A vaccine not foreseen by the study protocol administered during the period starting
             from 30 days before the booster dose of study vaccine and ending 30 days after*, with
             the exception of inactivated influenza vaccine and other vaccines given as a part of
             the national/regional immunization schedule, that are allowed at any time during the
             study period.

               -  In case an emergency mass vaccination for an unforeseen public health threat
                  (e.g.: a pandemic) is organised by the public health authorities, outside the
                  routine immunization program, the time period described above can be reduced if
                  necessary for that vaccine provided it is licensed and used according to its SPC
                  or Product Information (PI) and according to the local governmental
                  recommendations and provided a written approval of the Sponsor is obtained.

          -  Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
             medical history and physical examination (no laboratory testing required).

          -  Major congenital defects.

          -  Serious chronic illness.

          -  Administration of immunoglobulins and/or any blood products during the period within
             three months before the booster dose of study vaccines or planned administration
             during the study period.

          -  Encephalopathy defined as an acute, severe central nervous system disorder occurring
             within 7 days following vaccination with Infanrix hexa and generally consisting of
             major alterations in consciousness, unresponsiveness, generalised or focal seizures
             that persist more than a few hours, with failure to recover within 24 hours.

          -  History of Hib, diphtheria, tetanus, pertussis, pneumococcal, poliovirus and hepatitis
             B diseases since the conclusion visit of study 201330 [DTPA (BOOSTRIX)-048 PRI].

          -  Previous booster vaccination against Hib, diphtheria, tetanus, pertussis,
             pneumococcus, hepatitis B and/or poliovirus since the conclusion visit of study 201330
             [DTPA (BOOSTRIX)-048 PRI].

          -  History of any reaction or hypersensitivity likely to be exacerbated by any component
             of the vaccines (e.g: antigen, excipients).

          -  Hypersensitivity to latex.

          -  History of any neurological disorders or seizures.

          -  Any condition that in the judgment of the investigator would make intramuscular
             injection unsafe.

          -  Acute disease and/or fever at the time of vaccination.

               -  Fever is defined as temperature ≥ 37.5°C /99.5°F for oral, axillary or tympanic
                  route, or ≥ 38.0°C /100.4°F on rectal route.

               -  Subjects with a minor illness (such as mild diarrhoea, mild upper respiratory
                  infection) without fever may be enrolled at the discretion of the investigator.