Wyeth Study To Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00464945 | Completed Phase 3 Results

• 1 other identifier: 6096A1-3000
• Study Type: interventional
• Target: 269
• Locations: 1 country
• Sites: 9

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of manufacturing scale 13-valent pneumococcal conjugate (13vPnC) vaccine compared to pilot scale 13vPnC in healthy infants when given with routine pediatric vaccines.

Conditions

Pneumococcal Vaccines

Outcome Measures

Primary Outcomes (5)

• Percentage of Participants Achieving Antibody Level ≥0.35μg/mL in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series

  Percentages of participants achieving 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 (5 months of age)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant(Sig) (present and interfered with limb movement). Induration and erythema were scaled as Any (induration or erythema present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (Mod) (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may be represented in more than 1 category.

  During the 4-day period after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events (Infant Series)

  Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, use of medication (Meds)to prevent symptoms (sx), and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.

  During the 4-day period after each dose

• Percentage of Participants Reporting Pre-Specified Systemic Events (Toddler Series)

  Systemic events (fever ≥ 38 degrees Celsius \[C\] but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C), decreased appetite, irritability, increased sleep, decreased sleep, use of medication to prevent symptoms, and use of medication to treat symptoms) were collected using an electronic diary. Participants may be represented in more than 1 category.

  During the 4-day period after toddler dose

• Geometric Mean Antibody Concentration in 13vPnC Manufacturing Scale Group Relative to 13vPnC Pilot Scale Group After the 3-Dose Infant Series

  Antibody concentration/geometric mean concentration (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 (5 months of age)

Study Arms (2)

1

EXPERIMENTAL

Biological: 13-valent Pneumococcal Conjugate Vaccine

2

ACTIVE COMPARATOR

Biological: 13-valent Pneumococcal Conjugate Vaccine

Interventions

13-valent Pneumococcal Conjugate Vaccine BIOLOGICAL

1 dose at 2,3,4 and 12 months of age

1; 2

Eligibility Criteria

• Age: 41 Days - 99 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 2 months (42 to 98 days) at time of enrollment.
• Available for entire study period and whose parent/legal guardian can be reached by telephone.
• Healthy infant as determined by medical history, physical examination, and judgment of the investigator.
• Parent/legal guardian must be able to complete all relevant study procedures during study participation.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal, Hib conjugate, diphtheria, tetanus, pertussis, or polio vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, hepatitis B, measles, mumps, rubella, or pneumococcal vaccines.
• Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
• Known or suspected immune deficiency or suppression.
• History of culture-proven invasive disease caused by S pneumoniae.
• Major known congenital malformation or serious chronic disorders.
• 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. Does not include resolving syndromes due to birth trauma such as Erb palsy.
• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis®).
• Participation in another investigational or interventional trial. Participation in purely observational studies is acceptable.
• Infant who is a direct descendant (child or grandchild) of a member of the study site personnel.

Sponsors & Collaborators

• Wyeth is now a wholly owned subsidiary of Pfizer: lead

Study Sites (9)

Unknown Facility

Torun, Bydgoszcz, 87-100, Poland

Location

Unknown Facility

Krakow, Krakow, 30-663, Poland

Location

Unknown Facility

Krakow, Krakow, 31-442, Poland

Location

Unknown Facility

Siemianowice Śląskie, Krakow, 41-103, Poland

Location

Unknown Facility

Lubartowie, Lublin Voivodeship, 21-100, Poland

Location

Unknown Facility

Lublin, Lublin Voivodeship, 20-044, Poland

Location

Unknown Facility

Warsaw, Warszawa, 01-184, Poland

Location

Unknown Facility

Lodz, Łódź Voivodeship, 91-347, Poland

Location

Unknown Facility

Lodz, Łódź Voivodeship, 93-338, Poland

Location

Related Publications (1)

• Gadzinowski J, Albrecht P, Hasiec B, Konior R, Dziduch J, Witor A, Mellelieu T, Tansey SP, Jones T, Sarkozy D, Emini EA, Gruber WC, Scott DA. Phase 3 trial evaluating the immunogenicity, safety, and tolerability of manufacturing scale 13-valent pneumococcal conjugate vaccine. Vaccine. 2011 Apr 5;29(16):2947-55. doi: 10.1016/j.vaccine.2011.02.002. Epub 2011 Feb 16.

  PMID: 21335032 DERIVED

Results Point of Contact

• Title: U. S. Contact Center
• Organization: Wyeth

clintrialresults@wyeth.com

Study Officials

• Medical Monitor

  Wyeth is now a wholly owned subsidiary of Pfizer

  STUDY DIRECTOR

• Trial Manager

  For Poland, WPWZMED@wyeth.com

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2007
• First Posted: April 24, 2007
• Study Start: June 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: August 15, 2012
• Results First Posted: August 15, 2012

Record last verified: 2012-07

Locations

PL (9)