Vaccines, Pneumococcal Conjugate VaccinePhase 4NCT00581620
Study Evaluating Prevenar Immunogenicity in High Risk Children
A Phase 4 study testing pneumococcus conjugate vaccine in people with Vaccines, Pneumococcal Conjugate Vaccine, run by Wyeth is now a wholly owned subsidiary of Pfizer.
Trial summary
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population. Read more about this study
- Who is it for?
- Ages 2 months to 9 years
- Conditions the study is for
- Vaccines, Pneumococcal Conjugate Vaccine
- What is being tested?
- pneumococcus conjugate vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Sep 2007
- 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 2 months to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children between 2 months to 9 years old.
- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
- No history of seizures
Who cannot join
None listed.
About this study
Official title: To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
Read the detailed description
This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months
- Conditions
- Vaccines, Pneumococcal Conjugate Vaccine
- Being tested
- pneumococcus conjugate vaccine
- Keywords
- pneumococcus conjugated vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pneumococcus conjugate vaccineBiological
Infants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months.
| Study group | Role | What they receive |
|---|---|---|
| G1 | Active comparator | G1: HIV+ Receives: Biological: pneumococcus conjugate vaccine |
| G2 | Active comparator | G2: Sicle Cell disease Receives: Biological: pneumococcus conjugate vaccine |
| G3 | Active comparator | G3: neprotic symdrome Receives: Biological: pneumococcus conjugate vaccine |
| G4 | Active comparator | G4: Chronic pulmonary disease Receives: Biological: pneumococcus conjugate vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
Measured: 4 months
Secondary outcomes (1)
To evaluate tolerability of Prevenar* in that population.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2007 (estimated)
- Study startNov 2002
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vaccines, Pneumococcal Conjugate VaccineStudies 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
- 160 participants (actual)
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
- NCT00581620
- Sponsor's protocol ID
- 0887X-100974
- Status last verified
- Dec 2007
- First submitted
- 21 Dec 2007
- Last updated
- 27 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Humoral Immune Response to a Conjugated Pneumococcus Vaccine 7-Valent (Prevenar®) in Children From High Risk Groups.
- ClinicalTrials.gov ID
- NCT00581620
- Acronym / sponsor ID
- 0887X-100974
- Conditions
- Vaccines, Pneumococcal Conjugate Vaccine
- Keywords
- pneumococcus conjugated vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Wyeth is now a wholly owned subsidiary of PfizerIndustry (pharma, biotech, devices)
- Study start
- Nov 2002
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Dec 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.
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition. To evaluate tolerability of Prevenar® in that population.
Detailed description
This study will require 24 months to be completed. Each child will participate for a period of time according to age of the 1st dose of vaccination: infants up to 6 months of age will be evaluated for 5 months; infants between 7 to 11 months will be evaluated for 3 months; children between 12 months up to 9 years of age will be evaluate for 2 months
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| G1 | Active comparator | Biological: pneumococcus conjugate vaccineG1: HIV+ |
| G2 | Active comparator | Biological: pneumococcus conjugate vaccineG2: Sicle Cell disease |
| G3 | Active comparator | Biological: pneumococcus conjugate vaccineG3: neprotic symdrome |
| G4 | Active comparator | Biological: pneumococcus conjugate vaccineG4: Chronic pulmonary disease |
Who may qualify
- Ages
- 2 months to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children between 2 months to 9 years old.
- Children with HIV+; Sickle Cell disease; Neprotic symdrome; Chronic pulmonary disease
- No history of seizures
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 |
|---|---|---|
| pneumococcus conjugate vaccineInfants from 1 to 6 months: 3 doses at 2; 4; 6 m and booster from 12 to 15 months. | Biological | G1, G2, G3, G4 |
Primary outcome
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition
Time frame: 4 months
1 secondary outcome
To evaluate tolerability of Prevenar* in that population.
Time frame: 4 months
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 27 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?
A Phase 4 study testing pneumococcus conjugate vaccine in people with Vaccines, Pneumococcal Conjugate Vaccine, 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 3 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 27 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.
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?
To determine immunogenicity of the heptavalent CRM197 pneumococcal conjugate in children with immunodeficiency condition (time frame: 4 months). 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 27 Dec 2007.