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

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

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.

Study Overview

• Status: Completed
• Conditions: Vaccines, Pneumococcal
• Intervention / Treatment: Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80; Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

• Study Type: Interventional
• Enrollment (Actual): 500
• Phase: Phase 3

Contacts and Locations

Study Locations

• Poland
  • Bydgoszcz, Poland, 85-168
  • Debica, Poland, 39-200
  • Krakow, Poland, 31-202
  • Krakow, Poland, 30-663
  • Krakow, Poland, 31-422
  • Lodz, Poland, 91-347
  • Lubartow, Poland, 21-100
  • Lublin, Poland, 20-044
  • Oborniki Slaskie, Poland, 55-120
  • Poznan, Poland, 60-535
  • Poznan, Poland, 61-709
  • Siemianowice Slaskie, Poland, 41-103
  • Torun, Poland, 87-100
  • Trzebnica, Poland, 55-100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 3 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 γ-globulin (including hepatitis B immunoglobulin and monoclonal antibodies [eg, Synagis]).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Biological: 13 valent pneumococcal conjugate vaccine with Polysorbate 80
Active Comparator: 2	Biological: 13 valent pneumococcal conjugate vaccine without Polysorbate 80

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of Participants Reporting Pre-Specified Local Reactions	Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (Sig) (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness 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.	Within 4-days after each dose
Percentage of Participants Reporting Pre-Specified Systemic Events	Systemic events (fever [Fv] ≥ 37.5 degrees Celsius [C], fever ≥ 38 C but ≤ 39 C, fever >39 C but ≤ 40 C, fever > 40 C, decreased (decr)appetite, irritability, increased (incr)sleep, decreased sleep, hives, use of medication (meds) to treat symptoms (sx), and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.	Within 4-days after each dose

Collaborators and Investigators

• Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Investigators: Principal Investigator: Trial Manager, For Poland, WPWZMED@wyeth.com

Publications and helpful links

General Publications

• Gadzinowski J, Tansey SP, Wysocki J, Kopinska E, Majda-Stanislawska E, Czajka H, Korbal P, Pietrzyk JJ, Baker SA, Giardina PC, Gruber WC, Emini EA, Scott DA. Safety and immunogenicity of a 13-valent pneumococcal conjugate vaccine manufactured with and without polysorbate 80 given to healthy infants at 2, 3, 4 and 12 months of age. Pediatr Infect Dis J. 2015 Feb;34(2):180-5. doi: 10.1097/INF.0000000000000511.

Study record dates

Study Major Dates

• Study Start: November 1, 2006
• Primary Completion (Actual): June 1, 2008
• Study Completion (Actual): June 1, 2008

Study Registration Dates

• First Submitted: August 17, 2006
• First Submitted That Met QC Criteria: August 18, 2006
• First Posted (Estimate): August 21, 2006

Study Record Updates

• Last Update Posted (Estimate): August 15, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Vaccine; Infant
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Immunologic Factors; Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
• Other Study ID Numbers: 6096A1-009