DiphtheriaPhase 3NCT00316147
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
A Phase 3 study testing DTPa-HBV-IPV/Hib vaccine in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline at 4 sites in India.
Trial summary
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups: one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14… Read more about this study
- Who is it for?
- Ages 6 to 10 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Acellular Pertussis, Tetanus
- What is being tested?
- DTPa-HBV-IPV/Hib vaccine
- Type of treatment
- Vaccines
- How many people
- 224 participants
- Where
- 4 sitesIndia
- Study dates
- Dec 2005to Aug 2006
- Phase
- Phase 3
- 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 to 10 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
- Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.
Who cannot join
- Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
- Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
Trial locations and contacts
4 sites in 1 country.
India4 sites
GSK Investigational Site
Bangalore, 560034
GSK Investigational Site
Baroda, 390 001
GSK Investigational Site
Goa, 403202
GSK Investigational Site
New Delhi, 110002
About this study
Official title: Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:
- one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age
Read the detailed description
DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 \& Haemophilus influenzae type b vaccine
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis
- Being tested
- DTPa-HBV-IPV/Hib vaccine
- Keywords
- diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases
- Medical subject headings
- Diphtheria, Tetanus, Haemophilus Infections, Hepatitis B, Poliomyelitis, Whooping Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPa-HBV-IPV/Hib vaccineBiological
What is being measured
The primary outcome is the main question the study is designed to answer.
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
Secondary outcomes (3)
1M post-dose 3, antibody levels against all antigens
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Serious adverse events (SAEs) for entire study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2006 (estimated)
- Study startDec 2005
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiphtheriaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00316147
- Sponsor's protocol ID
- 104005
- Status last verified
- Sep 2016
- First submitted
- 21 Feb 2006
- Last updated
- 28 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age
- ClinicalTrials.gov ID
- NCT00316147
- Acronym / sponsor ID
- 104005
- Conditions
- Diphtheria, Acellular Pertussis, Tetanus, Haemophilus Influenzae Type b, Hepatitis B, Poliomyelitis
- Keywords
- diphtheria, tetanus, poliomyelitis, pertussis, hepatitis B, Prophylaxis, Haemophilus influenza type b diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Study completion
- Aug 2006 (actual)
- First posted
- 20 Apr 2006 (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.
In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:
- one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
- the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age
Detailed description
DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 \& Haemophilus influenzae type b vaccine
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 6 to 10 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
- Written informed consent obtained from the parent or guardian of the subject.
- Born after a normal gestation period (between 36 and 42 weeks).
- Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.
Key exclusion criteria (6 listed)
- Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs prior to the first vaccine dose.
- Any chronic drug therapy to be continued during the study period.
- Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
- Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
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 |
|---|---|---|
| DTPa-HBV-IPV/Hib vaccine | Biological | – |
Primary outcome
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
3 secondary outcomes
1M post-dose 3, antibody levels against all antigens
After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
Serious adverse events (SAEs) for entire study
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 Sep 2016.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTPa-HBV-IPV/Hib vaccine in people with Diphtheria and Acellular Pertussis, run by GlaxoSmithKline at 4 sites in India.
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 4 inclusion and 6 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 Sep 2016. 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 India. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers. 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 28 Sep 2016.