Study Evaluating a 13-valent Pneumococcal Conjugate Vaccine in Infants

NCT00366899 | Completed Phase 3 Results

• 1 other identifier: 6096A1-500
• Study Type: interventional
• Target: 605
• Locations: 1 country
• Sites: 13

Brief Summary

The purpose of this study is to assess the safety, tolerability and immunogenicity of a 13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given concomitantly with routine paediatric vaccinations in Italy.

Conditions

Vaccines, Pneumococcal

Keywords

Vaccine; Infants

Outcome Measures

Primary Outcomes (10)

• Percentage of Participants Reporting Pre-Specified Local Reactions

  Local reactions were collected using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (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 (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

  Systemic events (fever ≥ 37.5 degrees Celsius \[C\], fever ≥ 38 C but ≤ 39 C, fever \>39 C but ≤ 40 C, fever \> 40 C, decreased appetite, irritability, increased sleep, decreased sleep, hives, use of medication (meds) to treat symptoms, and use of medication to prevent symptoms) were reported using an electronic diary. Participants may be represented in more than 1 category.

  During the 4-day period after each dose

• Percentage of Participants Achieving Predefined Antibody Levels for Concomitant Antigen Pertussis, Hepatitis B, Haemophilus Influenzae Type b, Diphtheria, Tetanus and Polio After the 2-Dose Infant Series and After the Toddler Dose

  Percentage of Participants achieving predefined antibody threshold levels for Pertussis Toxoid (PT) ≥5 ELISA units per milliliter (EU/mL), Filamentous Haemagglutinin (FHA) ≥5 or ≥7.82 EU/mL, and Pertactin (PRN) ≥5 EU/mL, ≥10.0 Milli-International Units Per Milliliter (mIU/mL) for Hepatitis B, Haemophilus Influenzae type b (Hib) 0.15 μg/ml, 0.01 or 0.1 IU/mL for Diphtheria, 0.1 IU/mL for Tetanus, and ≥1:8 titer for Polio (Type 1, 2, and 3) with the corresponding 95% CI for antigens are presented.

  One month after the infant series (6 months of age) and after the toddler dose (12 months of age)

• Geometric Mean Antibody Concentration (GMC) of Pertussis in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose

  GMC of Pertussis (PT, FHA, PRN) were measured using an anti-Bordetella pertussis enzyme-linked immunosorbent assay (ELISA). Results were recorded in ELISA units per milliliter (EU/mL)

  one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

• Geometric Mean Antibody Concentration (GMC) for Hepatitis B in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After Toddler Dose

  GMC of anti-hepatitis B surface antigen (HBsAg)using an Food and Drug Administration (FDA) approved in vitro diagnostic kit.

  One month after the infant series (6 months of age) and the toddler dose (12 months of age)

• Geometric Mean Antibody Concentration (GMC) of Haemophilus Influenzae Type b (Hib) in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose

  GMC for Hib polyribosylribitol phosphate as measured by ELISA, expressed in micrograms per milliliter (μg/mL).

  one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

• Geometric Mean Antibody Concentration (GMC) of Diptheria and Tetanus in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose

  GMC of anti-diphtheria and anti-tetanus toxoids as measured by ELISA (IU/mL).

  one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

• Geometric Mean Antibody Concentration (GMC) of Polio Types 1, 2, and 3 in the 13vPnC Group Relative to the 7vPnC Group After the 2-Dose Infant Series and After the Toddler Dose

  GMC of Polio as measured using a polio in vitro plaque neutralization.

  one month after infant series dose 2 (6 months of age) and after the toddler dose (12 months of age)

• Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Group After the 2-Dose Infant Series and Before the Toddler Dose

  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 infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Group After the 2-Dose Infant Series and Before Toddler Dose

  Antibody GMC 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 infant series dose 2 (6 months of age) and before the toddler dose (11 months of age)

Secondary Outcomes (2)

• Percentage of Participants Achieving an Antibody Level of ≥0.35 μg/mL in the 13vPnC Relative to the 7vPnC Group After the Toddler Dose

  One month after the toddler dose (12 months of age)

• Geometric Mean Concentration (GMC) for Serotype-specific Pneumococcal Immunoglobulin G (IgG) Antibody in 13vPnC Relative to 7vPnC Group After the Toddler Dose

  One month after toddler dose (12 months of age)

Other Outcomes (2)

• Percentage of Subjects Achieving Antibody Titer (OPA) ≥1:8 in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose

  one month after infant series dose 2 and after the toddler dose

• Geometric Mean Antibody Titer (OPA) in 13vPnC Group After the 2-Dose Infant Series and the Toddler Dose

  one month after infant series dose 2 and after the toddler dose

Study Arms (2)

1

EXPERIMENTAL

13-valent pneumococcal conjugate vaccine

Biological: 13-valent pneumococcal conjugate vaccine

2

ACTIVE COMPARATOR

7-valent pneumococcal conjugate vaccine

Biological: 7 valent pneumococcal conjugate vaccine

Interventions

13-valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5 mL dose of 13vPnC given at 3, 5 and 11 months of age.

1

7 valent pneumococcal conjugate vaccine BIOLOGICAL

Single 0.5 mL dose of 7vPnC given at 3, 5 and 11 months of age.

2

Eligibility Criteria

• Age: 75 Days - 105 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged 3 months (75 to 105 days) at time of enrollment.
• Available for entire study period and whose parent(s)/legal guardian(s) could be reached by telephone.
• Healthy infant, as determined by medical history, physical examination, and judgment of the investigator.
• Parent(s)/legal guardian(s) had to be able to complete all relevant study procedures during study participation.

You may not qualify if:

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Previous vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B vaccines.
• A previous anaphylactic reaction to any vaccine or vaccine-related component.
• Contraindication to vaccination with Hib conjugate, diphtheria, tetanus, pertussis, polio, or hepatitis B, 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 or Hib.
• Major known congenital malformation or serious chronic disorder.
• 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.
• Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, Synagis® \[MedImmune\]).
• Participation in another investigational trial. Participation in purely observational studies was acceptable.
• Infant who was a direct descendant (eg, child or grandchild) of the study site personnel.

Sponsors & Collaborators

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

Study Sites (13)

Unknown Facility

Taranto, Apulia, 74100, Italy

Location

Unknown Facility

Napoli, Campania, 80122, Italy

Location

Unknown Facility

Napoli, Campania, 80139, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Rome, Lazio, 00100, Italy

Location

Unknown Facility

Rome, Lazio, 00165, Italy

Location

Unknown Facility

Genoa, Liguria, 16132, Italy

Location

Unknown Facility

Milan, Lombardy, 20122, Italy

Location

Unknown Facility

Novara, Piedmont, 28100, Italy

Location

Unknown Facility

Sassari, Sardinia, 07100, Italy

Location

Unknown Facility

Palermo, Sicily, 90100, Italy

Location

Unknown Facility

Ragusa, Sicily, 97100, Italy

Location

Unknown Facility

Florence, Tuscany, 50132, Italy

Location

Related Publications (1)

• Rodgers GL, Esposito S, Principi N, Gutierrez-Brito M, Diez-Domingo J, Pollard AJ, Snape MD, Martinon-Torres F, Gruber WC, Patterson S, Thompson A, Gurtman A, Paradiso P, Scott DA. Immune response to 13-valent pneumococcal conjugate vaccine with a reduced dosing schedule. Vaccine. 2013 Oct 1;31(42):4765-74. doi: 10.1016/j.vaccine.2013.08.009. Epub 2013 Aug 16.

  PMID: 23965217 DERIVED

MeSH Terms

Interventions

Heptavalent Pneumococcal Conjugate Vaccine

Intervention Hierarchy (Ancestors)

Pneumococcal Vaccines; Streptococcal Vaccines; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Vaccines, Combined

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 Italy, descresg@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: August 17, 2006
• First Posted: August 21, 2006
• Study Start: October 1, 2006
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: February 22, 2013
• Results First Posted: February 22, 2013

Record last verified: 2013-01

Locations

IT (13)