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

Vaccines, Pneumococcal Clinical Trial

Official title:

A Phase 3, Randomized, Double-blind Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine Manufactured With and Without Polysorbate 80 in Healthy Infants Given in a 2-, 3-, 4-, and 12-Month Schedule With Routine Pediatric Vaccinations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00366548
• Other study ID #: 6096A1-009
• Status: Completed
• Phase: Phase 3
• First received: August 17, 2006
• Last updated: July 6, 2012
• Start date: November 2006
• Est. completion date: June 2008

Study information

• Verified date: July 2012
• Source: Wyeth is now a wholly owned subsidiary of Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ministry of HealthUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine manufactured with Polysorbate 80 compared to a 13-valent pneumococcal conjugate (13vPnC) manufactured without Polysorbate 80 when given concomitantly with routine paediatric vaccinations.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 42 Days to 98 Days

Eligibility

Inclusion criteria:

1. Aged 2 months (42 through 98 days) at the time of enrollment.

2. Available for the entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.

3. In good health as determined by medical history, physical examination, and judgment of the investigator.

4. Parent(s)/legal guardian(s) were 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, or polio vaccines.

3. A previous anaphylactic reaction to any vaccine or vaccine-related component.

4. Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, 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.

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, or hydrocephalus), or other significant disorders. This did not include resolving syndromes because of birth trauma such as Erb palsy.

10. Receipt of blood products or ?-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Vaccines, Pneumococcal

Intervention

Biological:
• 13 valent pneumococcal conjugate vaccine with Polysorbate 80

• 13 valent pneumococcal conjugate vaccine without Polysorbate 80

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants Achieving Antibody Level =0.35µg/mL in 13vPnC+P80 Group Relative to 13vPnC-80 Group After the Infant Series	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold =0.35µg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after 3-dose infant series (at 5 months of age)	No
Primary	Geometric Mean Antibody Concentration (GMC) in 13vPnC+P80 Group Relative to 13vPnC-P80 Group After the 3-Dose Infant Series	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	One month after 3-dose infant series (at 5 months of age)	No
Secondary	Percentage of Participants Achieving Antibody Level = 0.35 µg/mL in the 13vPnC Group After the Toddler Dose	Percentages of participants achieving World Health Organization (WHO) predefined antibody threshold = 0.35 µg/mL along with the corresponding 95% CI for the 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	one month after the toddler dose (at 13 months of age)	No
Secondary	Geometric Mean Antibody Concentration (GMC) in 13vPnC Group Relative After the Toddler Dose	GMC as measured by enzyme-linked immunosorbent assay (ELISA) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented.	one month after the toddler dose (at 13 months of age)	No