Pneumococcal InfectionsPhase 4PCV13-BoboNCT01577771
Immunogenicity and Reactogenicity of PCV13 Among Infants and Children in Burkina Faso
A Phase 4 study testing Prevnar13 (manufactured by Pfizer) in people with Pneumococcal Infections, run by Agence de Médecine Préventive, France at 4 sites in Burkina Faso.
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. Read more about this study
- Who is it for?
- Ages Up to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- Prevnar13 (manufactured by Pfizer)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 663 participants
- Where
- 4 sitesBurkina Faso
- Study dates
- Feb 2013to May 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- Healthy volunteers accepted
- Child
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
Trial locations and contacts
4 sites in 1 country.
Burkina Faso4 sites
CSPS Accart-Ville
Bobo-Dioulasso, Region Des Hauts Bassins
Centre Muraz
Bobo-Dioulasso, Region Des Hauts-Bassins
CSPS Farakan
Bobo-Dioulasso, Region Des Hauts-Bassins
CSPS Guimbi
Bobo-Dioulasso, Region Des Hauts-Bassins
About this study
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
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).
- Conditions
- Pneumococcal Infections
- Being tested
- Prevnar13 (manufactured by Pfizer)
- Keywords
- Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prevnar13 (manufactured by Pfizer)Biological
Prevnar13 administered IM in the antero-lateral thigh
| Study group | Role | What they receive |
|---|---|---|
| Child | Active comparator | 1 dose of Prevnar13 at 2 to 4 years of age Receives: Biological: Prevnar13 (manufactured by Pfizer) |
| Toddler 1 dose | Experimental | Single dose of Prevnar13 at 12-15 months of age Receives: Biological: Prevnar13 (manufactured by Pfizer) |
| Toddler 2 dose | Active comparator | 2 doses of Prevnar13 2 months apart beginning at 12-15 months of age Receives: Biological: Prevnar13 (manufactured by Pfizer) |
| Infants 2+1 | Experimental | Infants receiving Prevnar13 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. Receives: Biological: Prevnar13 (manufactured by Pfizer) |
| Infants 3+0 | Active comparator | Infants receiving Prevnar13 at 6, 10 and 14 weeks Receives: Biological: Prevnar13 (manufactured by Pfizer) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serotype-specific pneumococcal serum IgG
Primary outcome in other age groups is:
- 3 months post-dose 1 (toddlers)
- 1 month post-vaccination (children)
Measured: 18 weeks for infants
Secondary outcomes (4)
Serotype-specific pneumococcal serum OPA
Measured: 18 weeks, 9 months and 10 months (infants), 3 months post-dose 1 (toddlers), 1 month post-vaccination (children)
Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage
Measured: 18 weeks, 9 months and 10 months (infants)
Adverse events following immunization
Measured: 1 and 3 days after each dose of vaccine (active surveillance), up to 28 days post-vaccination (passive surveillance)
Serotype-specific serum IgG
Measured: in infants, at 9 months and 10 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2012 (estimated)
- Study startFeb 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 663 participants (actual)
Sponsor and investigators
- Lead sponsor
- Agence de Médecine Préventive, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Bosco Ouedrogo, MD PhD, Principal investigator, Centre Muraz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01577771
- Sponsor's protocol ID
- PCV13-Immunogenicity-Bobo
- Other IDs
- WS779270
- Acronym
- PCV13-Bobo
- Status last verified
- Mar 2017
- First submitted
- 5 Apr 2012
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01577771
- Acronym / sponsor ID
- PCV13-Bobo / PCV13-Immunogenicity-Bobo
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal conjugate vaccine, Immunogenicity, Reactogenicity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 663 participants (actual)
- Lead sponsor
- Agence de Médecine Préventive, FranceUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 16 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Child | Active comparator | Biological: Prevnar13 (manufactured by Pfizer)1 dose of Prevnar13 at 2 to 4 years of age |
| Toddler 1 dose | Experimental | Biological: Prevnar13 (manufactured by Pfizer)Single dose of Prevnar13 at 12-15 months of age |
| Toddler 2 dose | Active comparator | Biological: Prevnar13 (manufactured by Pfizer)2 doses of Prevnar13 2 months apart beginning at 12-15 months of age |
| Infants 2+1 | Experimental | Biological: Prevnar13 (manufactured by Pfizer)Infants receiving Prevnar13 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. |
| Infants 3+0 | Active comparator | Biological: Prevnar13 (manufactured by Pfizer)Infants receiving Prevnar13 at 6, 10 and 14 weeks |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prevnar13 (manufactured by Pfizer)Prevnar13 administered IM in the antero-lateral thigh | Biological | Child, Infants 2+1, Infants 3+0, Toddler 1 dose, Toddler 2 dose |
Primary outcome
Serotype-specific pneumococcal serum IgG
Time frame: 18 weeks for infants
Primary outcome in other age groups is: * 3 months post-dose 1 (toddlers) * 1 month post-vaccination (children)
4 secondary outcomes
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)
Vaccine-type and non-vaccine type pneumococcal nasopharyngeal carriage
Time frame: 18 weeks, 9 months and 10 months (infants)
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)
Serotype-specific serum IgG
Time frame: in infants, at 9 months and 10 months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Bosco Ouedrogo, MD PhD principal investigator
Centre Muraz
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prevnar13 (manufactured by Pfizer) in people with Pneumococcal Infections, run by Agence de Médecine Préventive, France at 4 sites in Burkina Faso.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Burkina Faso. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serotype-specific pneumococcal serum IgG (time frame: 18 weeks for infants). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2017.