Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants.
Condition: Vaccines, Pneumococcal
Intervention: 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine
Intervention description: Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age; Single 0.5mL dose given at 2, 3, 4 and 11 to 12 months of age
Intervention MeSH terms: Vaccines; 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: 604.0
Sex: All
Minimum age: 56 Days
Maximum age: 112 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: safety; Vaccine

Summary:

      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to 7-valent pneumococcal conjugate
      (Prevenar/Prevenar®, 7vPnC), when given concomitantly with Infanrix hexa at 2, 3, 4, months
      (infant series) and at 11-12 months of age (toddler dose) in Germany.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Aged 2 months (56 to 112 days) at time of enrollment.

          2. Available for entire study period and whose parent(s) or 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) or 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
             hepatitis B vaccines.

          3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

          4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis,
             polio, or hepatitis B, or pneumococcal 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 or H influenzae type
             b.

          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. 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.