Study Evaluating 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 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.; Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 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: 605.0
Sex: All
Minimum age: 75 Days
Maximum age: 105 Days
Healthy volunteers: Accepts Healthy Volunteers
Keywords: Vaccine; Infants

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 vaccinations in Italy.
    

Eligibility criteria:

        Inclusion criteria:

          1. Aged 3 months (75 to 105 days) at 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. Born at greater than 32 weeks gestational age and greater than 2000 grams. Regardless
             of gestational age and birth weight, all subjects must have met inclusion criterion
             number 3.

          5. 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
             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 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. 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® [MedImmune]).

         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.