DiphtheriaPhase 3NCT01470287
Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent (DTwP-Hib-Hep B) Vaccine in Infants 6-8 Weeks of Age
A Phase 3 study testing DTwP-HepB-Hib Vaccine in people with Diphtheria and Tetanus, run by Novartis Vaccines at 3 sites in India.
Trial summary
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age. Read more about this study
- Who is it for?
- Ages 42 to 64 daysHealthy volunteers can take part
- Conditions the study is for
- Diphtheria, Tetanus, Pertussis
- What is being tested?
- DTwP-HepB-Hib Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 175 participants
- Where
- 3 sitesIndia
- Study dates
- Dec 2011to Apr 2012
- 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 42 to 64 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male and female subjects ≥ 42 days to ≤ 64 days of age.
- Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements
Who cannot join
- Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
- History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
- History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
- Administration of parenteral immunoglobulin preparation and/or blood products since birth.
Trial locations and contacts
3 sites in 1 country.
India3 sites
Rajarajeshwari Medical College and Hospital
Bangalore, Karnataka
Medical College Kolkata
Kolkata, West Bengal
Bharathi Vidyapeeth University
Pune, Maharashtra
About this study
Official title: A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age
This study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae B
- Being tested
- DTwP-HepB-Hib Vaccine
- Keywords
- Infants,, Immunogenicity,, Safety
- Medical subject headings
- Diphtheria, Tetanus, Whooping Cough, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTwP-HepB-Hib VaccineBiological
Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Biological: DTwP-HepB-Hib Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroprotection rate one month after the last dose of vaccine administration
Measured: One month after last vaccination
Secondary outcomes (1)
Seroprotection rate and GMCs one month after the last vaccine administration
Measured: One month after last vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startDec 2011
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 175 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470287
- Sponsor's protocol ID
- V66_05
- Status last verified
- May 2017
- First submitted
- 9 Nov 2011
- Last updated
- 19 May 2017
- Results posted
- No
Publications
Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, Lattanzi M. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants. Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 19.
PubMed 23783081
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase-III, Single Arm, Multi-Center, Open-Label Study to Assess the Immunogenicity, Safety and Tolerability of a Fully Liquid Pentavalent Vaccine (DTwP-Hib-HepB Vaccine) When Administered to Indian Infants at 6, 10, and 14 Weeks of Age
- ClinicalTrials.gov ID
- NCT01470287
- Acronym / sponsor ID
- V66_05
- Conditions
- Diphtheria, Tetanus, Pertussis, Hepatitis B, Hemophilus Influenzae B
- Keywords
- Infants,, Immunogenicity,, Safety
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 175 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 11 Nov 2011 (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 study will evaluate immunogenicity, safety and tolerability of fully liquid pentavalent vaccine (DTwP-Hib-HepB Vaccine) in infants 6-8 weeks of age.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Biological: DTwP-HepB-Hib Vaccine |
Who may qualify
- Ages
- 42 to 64 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Male and female subjects ≥ 42 days to ≤ 64 days of age.
- Written informed consent obtained from either parents/ legal guardian after the nature of the study has been explained according to local regulatory requirements
Key exclusion criteria (4 listed)
- Subjects whose parents or legal guardians are unwilling or unable to give written informed consent to participate in the study.
- History of previous immunization with a vaccine containing any of the 5 antigen components of investigational vaccine.
- History of anaphylactic shock(immediate hypersensitivity reactions), urticaria or other allergic reactions after previous vaccination or known hypersensitivity to any vaccine component.
- Administration of parenteral immunoglobulin preparation and/or blood products since birth.
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 |
|---|---|---|
| DTwP-HepB-Hib VaccineOpen label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age. | Biological | Arm 1 |
Primary outcome
Seroprotection rate one month after the last dose of vaccine administration
Time frame: One month after last vaccination
1 secondary outcome
Seroprotection rate and GMCs one month after the last vaccine administration
Time frame: One month after last vaccination
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 19 May 2017.
- Derived from this study: PubMed 23783081Eregowda A, Lalwani S, Chatterjee S, Vakil H, Ahmed K, Costantini M, Lattanzi M. A phase III single arm, multicenter, open-label study to assess the immunogenicity and tolerability of a pentavalent DTwP-HepB-Hib vaccine in indian infants. Hum Vaccin Immunother. 2013 Sep;9(9):1903-9. doi: 10.4161/hv.25166. Epub 2013 Jun 19.
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A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
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.
The record lists no contact. Use the official record to reach the sponsor.
3 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 DTwP-HepB-Hib Vaccine in people with Diphtheria and Tetanus, run by Novartis Vaccines at 3 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 2 inclusion and 4 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 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Seroprotection rate one month after the last dose of vaccine administration (time frame: One month after last vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01470287, which also lists 1 linked publication.
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 19 May 2017; AzTrials last refreshed its copy on 7 Nov 2026.