Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso

Pneumococcal Infections Clinical Trial

— PCV13-Bobo  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01577771
• Other study ID #: PCV13-Immunogenicity-Bobo
• Secondary ID: WS779270
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2012
• Last updated: March 3, 2017
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2017
• Source: Agence de Médecine Préventive, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 663
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Pneumococcal Infections

Intervention

Biological:
• Prevnar13 (manufactured by Pfizer)
Prevnar13 administered IM in the antero-lateral thigh

Locations

Country	Name	City	State
Burkina Faso	Centre Muraz	Bobo-Dioulasso	Region des Hauts-Bassins
Burkina Faso	CSPS Accart-Ville	Bobo-Dioulasso	Region des Hauts Bassins
Burkina Faso	CSPS Farakan	Bobo-Dioulasso	Region des Hauts-Bassins
Burkina Faso	CSPS Guimbi	Bobo-Dioulasso	Region des Hauts-Bassins

Sponsors (1)

Lead Sponsor	Collaborator
Agence de Médecine Préventive, France

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serotype-specific pneumococcal serum IgG	Primary outcome in other age groups is: 3 months post-dose 1 (toddlers); 1 month post-vaccination (children)	18 weeks for infants
Secondary	Serotype-specific pneumococcal serum OPA		18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children)
Secondary	Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage		18 weeks, 9 months and 10 months (infants)
Secondary	Adverse events following immunization		1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance)
Secondary	Serotype-specific serum IgG		in infants, at 9 months and 10 months of age