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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00366340
• Date of registration: 17/08/2006
• Prospective Registration: Yes
• 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 of the Safety, Tolerability, and Immunologic Non-Inferiority of a 13-valent Pneumococcal Conjugate Vaccine Compared to a 7-valent Pneumococcal Conjugate Vaccine in Healthy Infants Given With Routine Pediatric Vaccinations in Germany.
• Date of first enrolment: October 2006
• Target sample size: 604
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00366340
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Germany

Contacts

• Name: Trial Manager
• Affiliation: For Germany, [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 (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.



Age minimum: 56 Days
Age maximum: 112 Days
Gender: All

Health Condition(s) or Problem(s) studied

Vaccines, Pneumococcal

Intervention(s)

Biological: 7-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Primary Outcome(s)

Percentage of Participants Reporting Pre-Specified Local Reactions [Time Frame: Day 1 through 4 after each dose]

Geometric Mean Antibody Concentration of Haemophilus Influenzae Type b in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]

Geometric Mean Antibody Concentration in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (5 months of age)]

Geometric Mean Antibody Concentration of Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]

Percentage of Participants Achieving Antibody Titer =1:8 as Measured by Opsonophagocytic Activity Assay (OPA) in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series. [Time Frame: One month after 3-dose infant series (5 months of age)]

Geometric Mean Concentration in 13vPnC Group Relative to 7vPnC Group Before and After the Toddler Dose [Time Frame: Immediately before (12 months of age) and one month after the toddler dose (13 months of age)]

Geometric Mean Antibody Concentration of Diphtheria Toxoid in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]

Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series) [Time Frame: Day 1 through 4 after each dose]

Percentage of Participants Achieving Antibody Level =0.35 µg/mL in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (5 months of age)]

Geometric Mean Antibody Titer in 13vPnC Group Relative to 7vPnC Group After the 3-Dose Infant Series [Time Frame: One month after 3-dose infant series (5 months of age)]

Percentage of Participants Achieving Predefined Antibody Levels for Haemophilus Influenzae Type b, Diphtheria Toxoid, and Hepatitis B in 13vPnC Group Relative to 7vPnC Group After the Infant Series and After the Toddler Dose [Time Frame: One month after the infant series (5 months of age) ; one month after the toddler dose (13 months of age)]

Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series) [Time Frame: Day 1 through 4 after each dose]

Secondary ID(s)

6096A1-006

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 08/08/2012
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00366340