Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00384059
• Date of registration: 02/10/2006
• Prospective Registration: No
• Primary sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Public title: Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
• Scientific title: A Phase 3, Randomized, Active-Controlled, Double-Blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in the United Kingdom
• Date of first enrolment: October 2006
• Target sample size: 286
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00384059
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

United Kingdom

Contacts

• Name: Trial Manager
• Affiliation: For UK/Great Britian, [e-mail]

• Name: Medical Monitor
• Affiliation: Wyeth is now a wholly owned subsidiary of Pfizer

Key inclusion & exclusion 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.



Age minimum: 42 Days
Age maximum: 98 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal

Intervention(s)

Biological: 13-valent Pneumococcal Conjugate Vaccine

Biological: Pediacel

Biological: 7vPnC

Biological: Menitorix

Biological: NeisVac-C

Primary Outcome(s)

Geometric Mean Antibody Concentration in 13vPnC Group After the 2-dose Infant Series, Before and After the Toddler Dose. [Time Frame: one month after infant series dose 2 (5 months of age) and before and after toddler dose (12 months of age)]

Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [Time Frame: one month after infant series dose 2 (5 months of age)]

Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b (Hib) Polyribosylribitol Phosphate (PRP) as Measured by Enzyme-linked Immunosorbent Assay (ELISA) in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [Time Frame: one month after infant series dose 2 (5 months of age)]

Geometric Mean Antibody Concentration of Pertusis Filamentous Haemagglutinin (FHA), Pertussis Toxoid (PT), Pertactin (PRN), and Fimbrial Agglutinogens (FIM) as Measured by ELISA in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series [Time Frame: one month after infant series dose 2 (5 months of age)]

Percentage of Participants in the 13vPnC Group Achieving a Serotype-specific IgG Antibody Concentration =0.35 µg/mL Measured 1 Month After the 2-dose Infant Series, Before and After the Toddler Dose [Time Frame: one month after infant series dose 2 (5 months of age), before and after toddler dose (12 months of age)]

Percentage of Participants Achieving a Meningococcal C Serum Bactericidal Assay (SBA) Titer =1:8 and Predefined Antibody Levels for Pertussis and Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the 2-dose Infant Series. [Time Frame: One month after infant series dose 2 (5 months of age)]

Secondary Outcome(s)

Geometric Mean Antibody Concentration for Haemophilus Influenzae Type b PRP in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose. [Time Frame: one month after toddler dose (13 months of age)]

Geometric Mean Titer (GMT) of Meningococcal C Antigen as Measured by SBA in 13vPnC Group Relative to 7vPnC Group After the Toddler Dose [Time Frame: one month after toddler dose (13 months of age)]

Percentage of Participants Achieving a Predefined Antibody Level for Haemophilus Influenzae Type b in the 13vPnC Group Relative to the 7vPnC Group After the Toddler Dose. [Time Frame: one month after toddler dose (13 months of age)]

Percentage of Participants Achieving an SBA Titer =1:8 for Meningococcal C in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose. [Time Frame: one month after the toddler dose (13 months of age)]

Secondary ID(s)

6096A1-007

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 15/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00384059