Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Intervention: 13-valent Pneumococcal Conjugate Vaccine; 7vPnC; Pediacel; NeisVac-C; Menitorix
Intervention description: Single 0.5 mL dose given at 2, 3, 4, and 12 months of age; Single 0.5 mL dose given at 2, 3, 4 and 12 months of age; concommitant vaccine, both at arm 1 and at arm 2, at 2 months, 3 months and 4 months of age; concomittant vaccine, both at arm 1 and at arm 2, at 2 months and 4 months of age; concomitant vaccine, both at arm 1 and at arm 2, at 12 months of age
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 286.0
Sex: All
Minimum age: 42 Days
Maximum age: 98 Days
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine paediatric vaccines in the United Kingdom.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 2 months (42 to 98 days) at the time of enrollment.

          2. Available for entire study period and whose parent(s)/legal guardian(s) could be
             reached by telephone.

          3. Healthy infant, as determined by medical history, physical examination, and judgment
             of the investigator.

          4. Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures
             during study participation.

        Exclusion Criteria:

          1. Previous vaccination with licensed or investigational pneumococcal vaccine.

          2. Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or
             meningococcal vaccines.

          3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
             polio, pneumococcal conjugate, or meningococcal conjugate vaccines.

          5. Bleeding diathesis or condition associated with prolonged bleeding time that would
             contraindicate intramuscular injection.

          6. Known or suspected immune deficiency or suppression.

          7. History of culture-proven invasive disease caused by S pneumoniae, Neisseria
             meningitidis, or Hib.

          8. Major known congenital malformation or serious chronic disorder.

          9. Significant neurological disorder or history of seizure, including febrile seizure, or
             significant stable or evolving disorders, such as cerebral palsy, encephalopathy,
             hydrocephalus, or other significant disorders. This did not include resolving
             syndromes due to birth trauma such as Erb palsy.

         10. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and
             monoclonal antibodies; eg, Synagis®).

         11. Participation in another investigational trial. Participation in purely observational
             studies was acceptable.

         12. Infant who was a direct descendant (eg, child or grandchild) of the study site
             personnel.