DiphtheriaPhase 4NCT00877357
Safety, Long Term Immunogenicity and Lot Consistency Study of Liquid Pentavalent Combination Vaccine
A Phase 4 study testing Shan 5 in people with Diphtheria and Tetanus, run by Shantha Biotechnics Limited at 1 site in India.
Trial summary
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- Shan 5
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,000 participants
- Where
- 1 siteIndia
- Study dates
- Jan 2009to Feb 2013
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children in the age group six to eight weeks
- Born after a normal gestational period (36 - 42 weeks)
- Mother's HBsAg (hepatitis B surface antigen) assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
Who cannot join
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
- Previous vaccination or evidence of infection with DTP or Hib.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
- Major congenital or hereditary immunodeficiency.
- Infants born to mothers known to be HIV positive.
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- Infants having evidence of disease or fever, history of allergic disease or persistent hematological, hepatic, renal, cardiac or respiratory disease and signs of a CNS disorder at the time of vaccination.
- Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.40C, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures, encephalopathy and hypersensitivity reaction.
- Parent/s or guardian of subject unable to maintain diary card
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
School of Public Health, Post Graduate Institute of Medical Education and Research
Chandigarh, Uttarakhand, 160012
Madhu Gupta, MD, +91-172-2755223, madhugupta21@gmail.com
Madhu Gupta, MD
About this study
Official title: Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B
- Being tested
- Shan 5
- Keywords
- Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Lot Consistency, Long Term Immunogenicity, Reactogenicity, Healthy infants
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shan 5Biological
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
| Study group | Role | What they receive |
|---|---|---|
| Shan 5 Lot No 1 | Experimental | Not described Receives: Biological: Shan 5 |
| Shan 5 Lot No 2 | Experimental | Not described Receives: Biological: Shan 5 |
| Shan 5 Lot No 3 | Experimental | Not described Receives: Biological: Shan 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Solicited and unsolicited local and systemic adverse events following vaccination
Measured: 4 Months
Secondary outcomes (2)
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine
Measured: 12 Months
Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots
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 posted7 Apr 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2012 (estimated)
- Study completionFeb 2013 (estimated)
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.
- 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
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shantha Biotechnics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raman Rao, MD, Study director, Shantha Biotechnics Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877357
- Sponsor's protocol ID
- SBL/DTPwHBHib/WHOCON/2008/0100
- Status last verified
- Apr 2009
- First submitted
- 6 Apr 2009
- Last updated
- 6 May 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Multicentric Randomized Phase IV Post Marketing Safety, Immunogenicity and Lot-to-Lot Consistency Analysis of Shan 5 [DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine] in Indian Infants
- ClinicalTrials.gov ID
- NCT00877357
- Acronym / sponsor ID
- SBL/DTPwHBHib/WHOCON/2008/0100
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B
- Keywords
- Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Lot Consistency
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Shantha Biotechnics LimitedIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Feb 2013 (estimated)
- First posted
- 7 Apr 2009 (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.
A randomized phase IV study of the liquid pentavalent combination vaccine to evaluate the safety, immunogenicity (short term and long term) and clinical consistency of three production lots of the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Shan 5 Lot No 1 | Experimental | Biological: Shan 5 |
| Shan 5 Lot No 2 | Experimental | Biological: Shan 5 |
| Shan 5 Lot No 3 | Experimental | Biological: Shan 5 |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy children in the age group six to eight weeks
- Born after a normal gestational period (36 - 42 weeks)
- Mother's HBsAg (hepatitis B surface antigen) assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
Key exclusion criteria (9 listed)
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, un-registered drug, or vaccine other than the study vaccine (with the exception of oral polio vaccination OPV \& BCG vaccine) during the study period or within 30 days preceding the first dose of the study vaccine.
- Previous vaccination or evidence of infection with DTP or Hib.
- History of allergic disease or reaction likely to be exacerbated by any component of the vaccine including allergy to antibiotics.
- Major congenital or hereditary immunodeficiency.
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 |
|---|---|---|
| Shan 5Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine | Biological | Shan 5 Lot No 1, Shan 5 Lot No 2, Shan 5 Lot No 3 |
Primary outcome
Solicited and unsolicited local and systemic adverse events following vaccination
Time frame: 4 Months
2 secondary outcomes
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine
Time frame: 12 Months
Lot Consistency based on safety and Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine from each of the three lots
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2009.
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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.
Raman Rao, MD study director
Shantha Biotechnics Limited
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Shan 5 in people with Diphtheria and Tetanus, run by Shantha Biotechnics Limited at 1 site 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 9 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: status not confirmed, as of the sponsor's last update on 6 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mandeep S Dhingra, MD (+91-40-66301000 ext. 1801, drmandeep@shanthabiotech.co.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Solicited and unsolicited local and systemic adverse events following vaccination (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 6 May 2009.