Pneumococcal InfectionsNCT00488800
Safety and Local Tolerability of Prevenar in Indian Children
An observational study of Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children. Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by… Read more about this study
- Who is it for?
- Ages 6 weeks to 24 months
- Conditions the study is for
- Pneumococcal Infections
- What is being tested?
- pneumococcal conjugate vaccine
- Type of treatment
- Vaccines
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2006to Jan 2007
- Phase
- Observational
- 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 6 weeks to 24 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:
- For Primary Immunization Schedule:
- Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
- For Catch-up Immunization Schedule:
- Healthy male or female subjects 12-23 months of age
- EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.
Show all 13Show fewer
- A known or suspected history of Streptococcus pneumoniae disease.
- A previous anaphylactic or other severe vaccine-associated adverse event.
- A known or suspected impairment of immune system (including HIV infection), or recipient of immunosuppressive agents.
- A major congenital, developmental or serious chronic disorder.
- A confirmed or suspected underlying evolving neurological disorder or history of seizures.
- A history of thrombocytopenia or any coagulation disorder.
- Any acute illness at the time of vaccine administration
Who cannot join
None listed.
About this study
Official title: A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
This postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Read more
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
- Conditions
- Pneumococcal Infections
- Being tested
- pneumococcal conjugate vaccine
- Keywords
- Pneumococcal Infections/PC (Prevention & Control)
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcal conjugate vaccineBiological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJul 2006
- Primary completionJan 2007
- Study completionJan 2007
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Monitor, Study director, Wyeth is now a wholly owned subsidiary of Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00488800
- Sponsor's protocol ID
- 0887X-102324
- Status last verified
- Dec 2007
- First submitted
- 18 Jun 2007
- Last updated
- 28 Dec 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Postmarketing Surveillance Study Evaluating the Safety and Local Tolerance of PREVENAR in Indian Children
- ClinicalTrials.gov ID
- NCT00488800
- Acronym / sponsor ID
- 0887X-102324
- Conditions
- Pneumococcal Infections
- Keywords
- Pneumococcal Infections/PC (Prevention & Control)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 20 Jun 2007 (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 postmarketing surveillance study will evaluate the safety profile of Prevenar in Indian children.
Prevenar is indicated for active immunization of infants and children from 6 weeks of age through 9 years of age against invasive disease (including meningitis, bacteraemic pneumonia, bacteraemia, sepsis) caused by Streptococcus pneumoniae serotypes 4, 6B, 9V, 14, 18C, 19F and 23F.
Prevenar has been marketed in India since June 2006. The Board of Health in India has given restricted permission to import and market Prevenar. The present study is a post-approval regulatory commitment to the Board of Health in India.
This is an observational study and the protocol for the study has been approved by the Board of Health.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 6 weeks to 24 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (13 listed)
- Subjects must meet at least one of the following conditions to be eligible for inclusion in the study:
- Healthy male or female subjects 6 weeks + 5 days of age with no previous PREVENAR vaccination
- For Catch-up Immunization Schedule:
- Healthy male or female subjects 12-23 months of age
- EXCLUSION CRITERIA Subjects with any of the following conditions or characteristics will be excluded from the study.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| pneumococcal conjugate vaccine | Biological | – |
Primary outcome
Not reported in the source record.
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 28 Dec 2007.
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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.
Medical Monitor study director
Wyeth is now a wholly owned subsidiary of Pfizer
Questions about this trial
What is this clinical trial studying?
An observational study of Pneumococcal Infections, run by Wyeth is now a wholly owned subsidiary of Pfizer.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. 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 28 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
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.
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.
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 28 Dec 2007.