Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso (PCV13-Bobo)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Agence de Médecine Préventive, France
ClinicalTrials.gov Identifier:
NCT01577771
First received: April 5, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

This study aims to evaluate the immunogenicity and reactogenicity of 13-valent pneumococcal conjugate vaccine among infants, toddlers and children in Bobo-Dioulasso, Burkina Faso. Infants will be randomized to receive vaccine at 6, 10, 14 weeks or at 6 weeks, 14 weeks and 9 months of age. Serotype-specific serum IgG, OPA and nasopharyngeal colonization will be assessed at 6 weeks, 18 weeks, 9 months and 10 months of age. Toddlers 12-15 months of age will be randomized to receive either a single dose of PCV13 or 2 doses 2 months apart. Serotype-specific serum IgG and OPA will be measured pre-dose 1 and again 3 months later. Children 2 to 4 years of age will receive a single dose of PCV13 and have IgG and OPA assessments pre-vaccination and 1 month post-vaccination.

The immunogenicity and reactogenicity of PCV13 in the "standard schedule" groups (e.g. 6, 10, 14 weeks for infants and single dose for toddlers) will be compared to that observed in the PCV13 licensure trials. Within each age group the alternative schedule will be compared to the standard schedule in terms of immunogenicity and impact on nasopharyngeal carriage (infants only).


Condition Intervention Phase
Pneumococcal Infections
Biological: Prevnar13 (manufactured by Pfizer)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of 13-valent Pneumococcal Conjugate Vaccine Among Infants, Toddlers and Children in Bobo-Dioulasso, Burkina Faso: a Phase 4 Randomized Trial

Resource links provided by NLM:


Further study details as provided by Agence de Médecine Préventive, France:

Primary Outcome Measures:
  • Serotype-specific pneumococcal serum IgG [ Time Frame: 18 weeks for infants ] [ Designated as safety issue: No ]

    Primary outcome in other age groups is:

    • 3 months post-dose 1 (toddlers)
    • 1 month post-vaccination (children)


Secondary Outcome Measures:
  • Serotype-specific pneumococcal serum OPA [ Time Frame: 18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children) ] [ Designated as safety issue: No ]
  • Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage [ Time Frame: 18 weeks, 9 months and 10 months (infants) ] [ Designated as safety issue: No ]
  • Adverse events following immunization [ Time Frame: 1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance) ] [ Designated as safety issue: Yes ]
  • Serotype-specific serum IgG [ Time Frame: in infants, at 9 months and 10 months of age ] [ Designated as safety issue: No ]

Estimated Enrollment: 765
Study Start Date: February 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Child
1 dose of PCV13 at 2 to 4 years of age
Biological: Prevnar13 (manufactured by Pfizer)
PCV13 administered IM in the antero-lateral thigh
Experimental: Toddler 1 dose
Single dose of PCV13 at 12-15 months of age
Biological: Prevnar13 (manufactured by Pfizer)
PCV13 administered IM in the antero-lateral thigh
Active Comparator: Toddler 2 dose
2 doses 2 months apart beginning at 12-15 months of age
Biological: Prevnar13 (manufactured by Pfizer)
PCV13 administered IM in the antero-lateral thigh
Experimental: Infants 2+1
Infants receiving PCV13 at 6 weeks, 14 weeks and 9 months. Note: This infant immunization schedule is used in many European countries and in South Africa and has been shown to be immunogenic and effective. However, few head-to-head comparisons of the 2+1 and 3+0 schedules have been conducted.
Biological: Prevnar13 (manufactured by Pfizer)
PCV13 administered IM in the antero-lateral thigh
Active Comparator: Infants 3+0
Infants receiving PCV13 at 6, 10 and 14 weeks
Biological: Prevnar13 (manufactured by Pfizer)
PCV13 administered IM in the antero-lateral thigh

  Eligibility

Ages Eligible for Study:   up to 4 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Infants inclusion criteria

  • Child has birth weight ≥ 2500g
  • Child was born at ≥ 37 weeks of pregnancy or judged to be full-term by midwife or birth attendant
  • Mother has resided in Burkina Faso for at least 2 years
  • Mother has African nationality
  • Child will reside in Bobo-Dioulasso urban area for the duration of the study
  • Parent or guardian has given informed consent for child's participation

Infants exclusion criteria

  • Child was born with a congenital abnormality
  • Child has chronic or acute severe illness requiring specialized medical care
  • Child has a blood coagulation disorder
  • Mother has known HIV infection
  • Child is enrolled in another clinical trial
  • Child has known allergy to a component of the vaccine
  • Child received a pneumococcal vaccine outside the context of the trial
  • Child is 53 days of age or older at 6 week visit
  • Child weighs <3500g at the 6 week visit
  • Blood draw at 6 week visit was unsuccessful after 3 attempts

Toddlers inclusion criteria

  • Child is 12 to 15 months of age
  • Child has resided in Burkina Faso since birth
  • Child has African nationality
  • Child will reside in Bobo-Dioulasso urban area for the duration of the study
  • Parent or guardian has given informed consent for child's participation

Toddlers exclusion criteria

  • Child has visible signs of severe malnutrition
  • Child has chronic or acute severe illness requiring specialized medical care
  • Child has a blood coagulation disorder
  • Child has known HIV infection
  • Child is enrolled in another clinical trial
  • Child has known allergy to a component of the vaccine
  • Child received a pneumococcal vaccine outside the context of the trial
  • Child's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children (8.0 to 8.7 kg according to age)
  • Blood draw at first vaccination visit was unsuccessful after 3 attempts

Children inclusion criteria

  • Child is 2 to 4 years of age
  • Child has resided in Burkina Faso since birth
  • Child has African nationality
  • Child will reside in Bobo-Dioulasso urban area for the duration of the study
  • Parent or guardian has given informed consent for child's participation

Children exclusion criteria

  • Child has visible signs of severe malnutrition
  • Child has chronic or acute severe illness requiring specialized medical care
  • Child has a blood coagulation disorder
  • Child has known HIV infection
  • Child is enrolled in another clinical trial
  • Child has known allergy to a component of the vaccine
  • Child received a pneumococcal vaccine outside the context of the trial
  • Child's weight at first vaccination visit is lower than the 5th percentile of Burkinabe children
  • Blood draw at first vaccination visit was unsuccessful after 3 attempts
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01577771

Locations
Burkina Faso
CSPS Accart-Ville
Bobo-Dioulasso, Region des Hauts Bassins, Burkina Faso
Centre Muraz
Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
CSPS Guimbi
Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
CSPS Farakan
Bobo-Dioulasso, Region des Hauts-Bassins, Burkina Faso
Sponsors and Collaborators
Agence de Médecine Préventive, France
Investigators
Principal Investigator: Jean-Bosco Ouedrogo, MD PhD Centre Muraz
  More Information

No publications provided

Responsible Party: Agence de Médecine Préventive, France
ClinicalTrials.gov Identifier: NCT01577771     History of Changes
Other Study ID Numbers: PCV13-Immunogenicity-Bobo, WS779270
Study First Received: April 5, 2012
Last Updated: January 7, 2014
Health Authority: Burkina Faso: Direction Generale de la Pharmacie, du Medicament et des Laboratoires

Keywords provided by Agence de Médecine Préventive, France:
Pneumococcal conjugate vaccine
Immunogenicity
Reactogenicity

Additional relevant MeSH terms:
Pneumococcal Infections
Streptococcal Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on July 26, 2014