DiphtheriaPhase 4NCT00617812
Safety and Immunogenicity Study of a Liquid Pentavalent Combination Vaccine
A Phase 4 study testing Shan5 in people with Diphtheria and Tetanus, run by Shantha Biotechnics Limited at 4 sites in India.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule. 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?
- Shan5
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 4 sitesIndia
- Study dates
- Mar 2008to May 2009
- 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 assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents willing to fill the Diary Card
Who cannot join
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of 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.
- 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 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.
Show all 9Show fewer
- Infants showing any of the following reactions after any dose of study vaccine will be withdrawn for subsequent doses: body temperature more than 40.4 degree Celsius, persistent screaming or crying for 3 hours within 48 hours of vaccination, seizures,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
- Simultaneous participation in any other clinical study
Trial locations and contacts
4 sites in 1 country.
India4 sites
Ankur Institute of Child Health
Ahmedabad, Gujarat, 380009
Deccan College of Medical Sciences
Hyderabaad, Andhra Pradesh, 500058
Institute of Child Health
Kolkata, West Bengal, 700017
JSS Medical College
Mysore, Karnataka, 570015
About this study
Official title: An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B
- Being tested
- Shan5
- Keywords
- Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, 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.
Shan5Biological
Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine
| Study group | Role | What they receive |
|---|---|---|
| Shan5 | Experimental | Not described Receives: Biological: Shan5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.
Measured: 4 months
Secondary outcomes (1)
Solicited and unsolicited local and systemic adverse events following vaccination
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 posted18 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionApr 2009
- Study completionMay 2009
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shantha Biotechnics Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Raman Rao, MD, Study director, Shantha Biotechnics Limited, Hyderabad, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00617812
- Sponsor's protocol ID
- SBL/DTPwHB-Hib/PMS/2007/0100
- Status last verified
- Jun 2009
- First submitted
- 6 Feb 2008
- Last updated
- 25 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Multicentric Study to Evaluate the Immunogenicity and Safety of Indigenously Developed DTPwHB-Hib (Liquid) Pentavalent Combination Vaccine (Shan 5) in Indian Infants.
- ClinicalTrials.gov ID
- NCT00617812
- Acronym / sponsor ID
- SBL/DTPwHB-Hib/PMS/2007/0100
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus Influenzae Type B
- Keywords
- Vaccine, Prevention, Diphtheria, Tetanus, Pertussis, Hepatitis B, Haemophilus influenzae type b, Healthy infants
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Shantha Biotechnics LimitedIndustry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 18 Feb 2008 (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.
The purpose of this study is to evaluate the safety and immunogenicity of an indigenously developed liquid pentavalent (diphtheria, tetanus, pertussis, hepatitis B and Hib) combination vaccine in healthy Indian infants as a part of the routine immunization in accordance with the EPI schedule.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shan5 | Experimental | Biological: Shan5 |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy children in the age group six to eight weeks
- Born after a normal gestational period (36 - 42 weeks)
- Mother's HBsAg assured negative.
- Father, mother or legally acceptable representative properly informed about the study and having signed the informed consent form.
- Parents willing to fill the Diary Card
Key exclusion criteria (9 listed)
- Administration of immunoglobulin or any blood products since birth.
- Use of any investigational, on-registered drug, or vaccine other than the study vaccine (with the exception of 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.
- 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 |
|---|---|---|
| Shan5Diphtheria, tetanus, whole cell pertussis, recombinant hepatitis B and Hib tetanus toxoid conjugate pentavalent liquid combination vaccine | Biological | Shan5 |
Primary outcome
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine.
Time frame: 4 months
1 secondary outcome
Solicited and unsolicited local and systemic adverse events following vaccination
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 25 Jun 2009.
Related trials for Diphtheria
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
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, Hyderabad, India
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 Shan5 in people with Diphtheria and Tetanus, run by Shantha Biotechnics Limited 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 5 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: finished, as of the sponsor's last update on 25 Jun 2009. 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 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?
Seroprotection rates for Diphtheria, Tetanus, Pertussis, Hepatitis B and Hib following 3 doses of the vaccine. (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 25 Jun 2009.