Immune Response to DTP-HB-Hib VaccinePhase 4NCT02409095
Study Comparing DTP-HB-Hib by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Infants
A Phase 4 study testing DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI) and Needle & Syringe in people with Immune Response to DTP-HB-Hib Vaccine, run by Serum Institute of India Pvt. Ltd. at 3 sites in India.
Trial summary
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Immune Response to DTP-HB-Hib Vaccine
- What is being tested?
- DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI) and Needle & Syringe
- Type of treatment
- Vaccines, Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 211 participants
- Where
- 3 sitesIndia
- Study dates
- Jan 2015to Mar 2016
- 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
- Normal healthy infants of age 6-8 weeks at the time of the first vaccination.
- Born after a normal gestation period (36-42 weeks).
- Parents of subjects willing to give written informed consent.
- Parents willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
- The participant should be the resident of study area
Who cannot join
- Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period.
- Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of ≥ 1 week.
- Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness.
- Infants who have received blood or blood-derived products in the past.
- History of diphtheria, tetanus, pertussis, and hepatitis B or Haemophilus influenzae type b (confirmed either clinically, serologically or microbiologically).
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- Previous history of vaccination against the diphtheria, tetanus, pertussis or Hib.
- Known history of a bleeding disorder contraindicating intramuscular vaccination.
- History of any neurological disorder or history of seizure (febrile or afebrile), or encephalopathy, encephalitis, hypotonic-hyporesponsive episode.
- History of febrile illness at the time of inclusion is a temporary exclusion criterion.
- Acute or chronic, clinically significant pulmonary, endocrine, autoimmune, cardiovascular, metabolic, hepatic or renal functional abnormality, as determined by medical history, and physical examination tests, which in the opinion of the investigator, might interfere with the study objectives
- Infant with any other condition, which, in the opinion of the investigator would jeopardize the safety or rights of the infant participating in the study or making it unlikely the subject could complete the protocol
Trial locations and contacts
3 sites in 1 country.
India3 sites
Dept of Pediatrics, Sri Ramachandra Medical Centre, No. 1, Ramachandra nagar, Porur,
Chennai, Tamil Nadu, 600116
Department of Pediatrics, KEM Hospital Research Centre, Sardar Moodliar Road, Rasta Peth,
Pune, Maharashtr, 411011
Department of Pediatrics, Bharati Vidyapeeth Deemed University Medical College and Hospital, Satara Road, Katraj, Dhankawadi
Pune, Maharasthra, 411043
About this study
Official title: A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India
This is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
Read the detailed description
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of Serum Institute of India Ltd. delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B (HBsAg) and Hemophilus Influenza B at 28 days after administration of a third dose of the vaccine.
- Conditions
- Immune Response to DTP-HB-Hib Vaccine
- Being tested
- DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI), Needle & Syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTP-HB-Hib vaccineBiological
Also called Pentavac
Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.
Disposable Syringe Jet Injector (DSJI)Device
Also called Stratis
Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
Needle & SyringeOther
The conventional needle syringe that is routinely used for vaccination.
| Study group | Role | What they receive |
|---|---|---|
| DISPOSABLE-SYRINGE JET INJECTOR (DSJI) | Experimental | Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc Receives: Biological: DTP-HB-Hib vaccine; Device: Disposable Syringe Jet Injector (DSJI) |
| NEEDLE & SYRINGE (N-S) | Active comparator | Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via conventional needle and Syringe Receives: Biological: DTP-HB-Hib vaccine; Other: Needle & Syringe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis
Measured: one month after administration of third dose of the vaccine
Secondary outcomes (3)
Occurrence of solicited reactions
Measured: within 4 days following the administration of each of the three vaccine dose
Occurrence of adverse event
Measured: 84 days after first vccine dose
Occurrence of serious adverse event
Measured: 84 days after first vccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionFeb 2016
- Study completionMar 2016
Why it stopped: Due to increased rate of local injection site reactions in the DSJI group.
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 Immune Response to DTP-HB-Hib 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 211 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02409095
- Sponsor's protocol ID
- Penta-01/12
- Status last verified
- Sep 2018
- First submitted
- 12 Jan 2015
- Last updated
- 11 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Bavdekar A, Malshe N, Ravichandran L, Sapru A, Kawade A, Lalwani S, Palkar S, Hanumante N, Gunale B, Kapse D, Chaudhari A, Miller T, Saganic L, Jarrahian C, McGray S, Zehrung D, Kulkarni PS. Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India. Contemp Clin Trials Commun. 2019 Jan 9;14:100321. doi: 10.1016/j.conctc.2019.100321. eCollection 2019 Jun.
PubMed 30899835
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Non-Inferiority, Observer Blind, Randomized Clinical Study Comparing Safety And Immunogenicity Of DTP-HB-Hib Vaccination by Disposable-Syringe Jet Injector To Vaccination By Needle And Syringe In Healthy Infants In India
- ClinicalTrials.gov ID
- NCT02409095
- Acronym / sponsor ID
- Penta-01/12
- Conditions
- Immune Response to DTP-HB-Hib Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to increased rate of local injection site reactions in the DSJI group.
- Enrolment
- 211 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- PATH
- Study start
- Jan 2015
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 6 Apr 2015 (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 is a study planned to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of SIIL delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants aged 6 to 8 weeks at the time of enrollment.
It will provide information to aid managers, device regulatory control officials, immunization programs, and clinicians who make decisions on safe clinical practice standards.
Detailed description
This is a randomized, observer blind, non-inferior, parallel group, multi-centre clinical study to determine and compare immunogenicity and reactogenicity of DTP-HB-Hib vaccine of Serum Institute of India Ltd. delivered either with disposable-Syringe Jet Injector (DSJI) or disposable-syringe needle in total 340 Indian infants. Sera samples will be analyzed by ELISA for seroconversion / seropositivity for each individual component of vaccine i.e. Diphtheria, Tetanus, Pertussis, Hepatitis B (HBsAg) and Hemophilus Influenza B at 28 days after administration of a third dose of the vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DISPOSABLE-SYRINGE JET INJECTOR (DSJI) | Experimental | Biological: DTP-HB-Hib vaccine, Device: Disposable Syringe Jet Injector (DSJI)Subjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via Disposable Syringe Jet Injector (Brand Name:Stratis) of Pharmajet Inc |
| NEEDLE & SYRINGE (N-S) | Active comparator | Biological: DTP-HB-Hib vaccine, Other: Needle & SyringeSubjects in this arm will be given three deep intramuscular doses, 0.5 mL each dose 4 weeks apart, of Serum Institute of India Ltd.'s DTP-HB-Hib vaccine (Brand name: Pentavac) via conventional needle and Syringe |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Normal healthy infants of age 6-8 weeks at the time of the first vaccination.
- Born after a normal gestation period (36-42 weeks).
- Parents of subjects willing to give written informed consent.
- Parents willing to comply with study protocol.
- Free of obvious health problems as established by medical history and screening evaluation including clinical examination.
Key exclusion criteria (12 listed)
- Infant subject participating in other clinical trial or planned participation in another clinical trial during the present trial period.
- Infant with congenital or acquired immunodeficiency, malignancy or receiving immunosuppressive therapy such as systemic corticosteroids therapy for a period of ≥ 1 week.
- Infant with history of allergy or systemic hypersensitivity to any of the vaccine component or history of a life-threatening reaction to the trial vaccine or a vaccine containing the same substances.
- Infant with any chronic illness including hepatic, renal, respiratory, CVS, endocrine and neurological illness.
- Infants who have received blood or blood-derived products in the past.
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 |
|---|---|---|
| DTP-HB-Hib vaccineAlso: PentavacDiphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases. | Biological | DISPOSABLE-SYRINGE JET INJECTOR (DSJI), NEEDLE & SYRINGE (N-S) |
| Disposable Syringe Jet Injector (DSJI)Also: StratisStratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA. | Device | DISPOSABLE-SYRINGE JET INJECTOR (DSJI) |
| Needle & SyringeThe conventional needle syringe that is routinely used for vaccination. | Other | NEEDLE & SYRINGE (N-S) |
Primary outcome
Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis
Time frame: one month after administration of third dose of the vaccine
3 secondary outcomes
Occurrence of solicited reactions
Time frame: within 4 days following the administration of each of the three vaccine dose
Occurrence of adverse event
Time frame: 84 days after first vccine dose
Occurrence of serious adverse event
Time frame: 84 days after first vccine dose
Results and safety
The study was stopped early (reason given: Due to increased rate of local injection site reactions in the DSJI group.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2018.
- Derived from this study: PubMed 30899835Bavdekar A, Malshe N, Ravichandran L, Sapru A, Kawade A, Lalwani S, Palkar S, Hanumante N, Gunale B, Kapse D, Chaudhari A, Miller T, Saganic L, Jarrahian C, McGray S, Zehrung D, Kulkarni PS. Clinical study of safety and immunogenicity of pentavalent DTP-HB-Hib vaccine administered by disposable-syringe jet injector in India. Contemp Clin Trials Commun. 2019 Jan 9;14:100321. doi: 10.1016/j.conctc.2019.100321. eCollection 2019 Jun.
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 4 study testing DTP-HB-Hib vaccine, Disposable Syringe Jet Injector (DSJI) and Needle & Syringe in people with Immune Response to DTP-HB-Hib Vaccine, run by Serum Institute of India Pvt. Ltd. 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 6 inclusion and 12 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: stopped early, as of the sponsor's last update on 11 Sep 2018. 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 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 was stopped early (reason given: Due to increased rate of local injection site reactions in the DSJI group.). Results are not available in the source record.
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?
Percentage of seroprotection and geometric mean titers (GMT) for diphtheria, tetanus, hepatitis-B, H. Influenzae and percentage sero-positivity and GMT for B. Pertussis (time frame: one month after administration of third dose of the vaccine). 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 NCT02409095, 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 11 Sep 2018.