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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00366548
Other study ID # 6096A1-009
Secondary ID
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


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
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