Diptheria ImmunizationPhase 3NCT06413121
Clinical Study to Assess the Immunogenicity and Safety of Hexavalent Vaccine Containing Reduced Dose IPV
A Phase 3 study testing Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV and Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV in people with Diptheria Immunization and Tetanus Immunization, run by Serum Institute of India Pvt. Ltd. at 11 sites in 2 countries.
Trial summary
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent… Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization
- What is being tested?
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV and Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,557 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 9 May 2024to 20 Feb 2026
- 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 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female infants aged 6-8 weeks at the time of first vaccination.
- Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
- Informed consent form signed by at least one parent.
- Infants born at full term pregnancy (≥ 37 weeks).
- Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment.
- Willingness of subjects' parent to comply with the requirements of the protocol.
Who cannot join
- History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae type b/ poliomyelitis infection(s).
- Presence of fever ≥ 38°C/ 100.4°F.
- Acute illness of moderate to severe intensity according to the clinical judgment of the investigator .
- Receipt of antibiotics in the past 3 days
- Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period.
- Administration of any vaccine (except OPV during government immunization campaign) in the 4 weeks preceding the first trial vaccination.
Show all 17Show fewer
- History of major congenital defects or illness that require medical therapy, as determined by medical history or clinical assessment.
- History of any clinically significant chronic disease that in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
- History of anaphylaxis, or any serious vaccine reaction, or hypersensitivity/allergy to any vaccine or components of study vaccine.
- Infants with known or suspected impairment of the immune function, or those receiving immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy or received immunosuppressive therapy prior to study entry
- Presence of evolving or changing neurological disorder or infant with a history of seizures and/or encephalopathy.
- Known thrombocytopenia or a bleeding disorder.
- Known personal or maternal history of HIV, Hepatitis B or Hepatitis C seropositivity.
- Planned surgery during the study.
- Receipt of blood or blood-derived products or immunoglobulins or planned administration during the trial which might interfere with the assessment of the immune response.
- Participation in another clinical trial 4 weeks preceding the trial enrolment or planned participation during the present trial period in another clinical trial.
- Infants whose families are planning to leave the area of the study site before the end of the study period.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
India8 sites
Post Graduate Institute of Medical Education and Research (PGIMER)
Chandigarh, Chandigarh, 160012
Sri Ramachandra Medical Centre, Chennai
Chennai, Tamil Nadu, 600116
Institute of Child Health, Kolkata
Kolkata, West Bengal, 700017
Manipal Academy of Higher Education, Manipal
Mangalore, Karnataka, 576104
JSS Medical College and Hospital
Mysore, Karnataka, 570004
Hamdard Institute of Medical Sciences and Research (HIMSR) with Centre for health research & Development, Society for applied studies, Hakeem Abdul Hameed Centenary Hospital (HAHCH)
New Delhi, National Capital Territory of Delhi, 110062
Bharati Vidyapeeth Medical College and Hospital, Pune
Pune, Maharashtra, 411043
KEM Hospital and Research Centre, Vadu
Pune, Maharashtra, 412216
Bangladesh3 sites
International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b), Matlab Field office, MHRC Internal Road, Matlab Bazar
Chāndpur, 3640
International Centre for Diarrhoeal Disease Research, Bangladesh (ICDDR,B), Kamalapur Field office, Lichubagan Rd
Dhaka, Dhaka Division, 1204
International Centre for Diarrhoeal Disease Research, Bangladesh (Icddr,b), Clinical Trial Unit (CTU), Adjacent to the main center, 68, Shaheed Tajuddin Ahmed Sarani, Mohakhali, Dhaka
Dhaka, Dhaka Division, 1212
About this study
Official title: An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL®
In 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV.
SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens.
Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.
Read the detailed description
This is an observer-blind, randomized, active-controlled, multi-centric study in healthy infants and toddlers to assess the immunogenicity and safety of SIIPL reduced IPV hexavalent vaccine in comparison with the licensed SIIPL HEXASIIL® vaccine.
One thousand five hundred and fifty-seven infants aged 6-8 weeks (42 to 56 days, both days inclusive) will be randomized in a 2:1 ratio (1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL® group), to receive a 3-dose primary vaccination series followed by their booster doses, respectively. The safety and immunogenicity data collected up to 28 days following third vaccination i.e., Visit 7, shall be submitted to the regulatory authority. All subjects will be followed up further for booster dose. After Visit 7 (i.e., 28 days following completion of primary vaccination series) subjects will be followed up for safety every 3 months starting from the age of 6 months (i.e., at 6, 9, 12, 15, 18, and 21 months of age) until they receive the booster dose anytime between 12-24 months. There will be post booster follow up visit (EOS visit) 28 days after the booster immunization i.e., Visit 10 to assess the safety and post booster immunogenicity.
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization, Haemophilus Influenzae Type B Immunization, Polio Immunization
- Being tested
- Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV, Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPVBiological
Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.
Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPVBiological
Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months.
| Study group | Role | What they receive |
|---|---|---|
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV | Experimental | Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. Receives: Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV |
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV | Active comparator | Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. Receives: Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine.
Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3, seroresponse for anti-B. pertussis and seroconversion for anti-pertussis toxin, 28 days post completion of a 3-dose primary vaccination series.
Measured: 28 days post completion of 3-dose primary vaccination series in infants.
Secondary outcomes (2)
Assessment of occurrence, severity, and relationship of adverse events (AEs)
local and systemic solicited AEs, unsolicited AEs and serious adverse events (SAEs)
Measured: Local and systemic solicited AEs occurring up to 7 days following each vaccination, unsolicited AEs and SAEs till 28 days post completion of a 3-dose primary vaccination series.
Assessment of immunogenicity of SIIPL reduced IPV hexavalent vaccine with the comparator vaccine, SIIPL HEXASIIL® and to assess lot-to-lot consistency among 3 lots of SIIPL reduced IPV Hexavalent vaccine
Geometric mean concentrations/ Geometric mean titres (GMCs/GMTs) for anti diphtheria, anti-tetanus, anti-B. pertussis, anti-pertussis toxin, anti-HBsAg, anti- polyribosylribitol phosphate (PRP) and anti-polio types 1, 2 \& 3 antibodies, 28 days post completion of the 3 dose primary vaccination series in infants.
Measured: 28 days post completion of the 3-dose primary vaccination series in infants.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start9 May 2024
- Primary completion4 Mar 2025
- Study completion20 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diptheria ImmunizationStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,557 participants (actual)
Sponsor and investigators
- Lead sponsor
- Serum Institute of India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anand Kawade, Principal investigator, KEM Hospital Research Centre, Pune, IndiaSonali Palkar, Principal investigator, Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, IndiaM D Ravi, Principal investigator, JSS Hospitla, Mysore, IndiaVeena Kamat, Principal investigator, Manipal Academy of Higher Education, Kasturba Medical College, Udipi and Karkala,IndiaP Umapathy, Principal investigator, Sri Ramchndra Institute of Higher Education and Research, Chennai, IndiaKheya Ghosh, Principal investigator, Institute of Child Health, Kolkata, IndiaMadhu Gupta, Principal investigator, Post Graduate Institute of Medical Education and Research, Chandigarh, IndiaAfreen khan, Principal investigator, Hamdard Institute of Medical Sciences and Research (HIMSR), New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413121
- Sponsor's protocol ID
- SII-wHEXA/IN-03
- Status last verified
- Jun 2026
- First submitted
- 3 May 2024
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Summary results for primary and secondary objectives
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observer-blind, Randomized, Active-controlled, Multi-centric Phase III Study to Assess Immunogenicity and Safety of Hexavalent (DTwP-Hepatitis B-IPV-Hib) Vaccine Containing Reduced Dose IPV in Comparison With HEXASIIL®
- ClinicalTrials.gov ID
- NCT06413121
- Acronym / sponsor ID
- SII-wHEXA/IN-03
- Conditions
- Diptheria Immunization, Tetanus Immunization, Pertussis Immunization, Hepatitis B Immunization, Haemophilus Influenzae Type B Immunization, Polio Immunization
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,557 participants (actual)
- Lead sponsor
- Serum Institute of India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 May 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 20 Feb 2026 (actual)
- First posted
- 14 May 2024 (actual)
- 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 2012, the World Health Assembly (WHA) endorsed the proposed Polio Endgame Strategy, which includes withdrawal of the Sabin-virus type 2 antigen-responsible for an estimated 95% of vaccine derived cases of polio by replacing the trivalent Oral Polio Vaccine (OPV) in the routine immunization schedule with a bivalent OPV that lacks the type 2 Sabin virus. Since the WHA resolution, all countries that were solely using OPV have either introduced Inactivated Polio Vaccine (IPV) into their routine immunization schedule or decided to introduce IPV but have been unable to secure supply. The global demand for IPV has therefore substantially increased in just a few years. Many initiatives are ongoing to meet the increasing demand for IPV. One potential approach is the reduction of the amount of antigen per vaccine dose. Therefore, to enhance the affordability, effectiveness and accessibility of IPV.
SIIPL has manufactured hexavalent combination vaccine containing diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and a reduced dose of three IPV antigens.
Based on available published data, reduction of the antigen content of each of the three poliovirus types in IPV is feasible, without substantially compromising the immunogenicity of the vaccine. Advantages of a reduction in antigen content are two-fold: increased availability of IPV and reduced cost, both of major importance for the global eradication programme.
Detailed description
This is an observer-blind, randomized, active-controlled, multi-centric study in healthy infants and toddlers to assess the immunogenicity and safety of SIIPL reduced IPV hexavalent vaccine in comparison with the licensed SIIPL HEXASIIL® vaccine.
One thousand five hundred and fifty-seven infants aged 6-8 weeks (42 to 56 days, both days inclusive) will be randomized in a 2:1 ratio (1038 infants in SIIPL reduced IPV hexavalent group and 519 in SIIPL HEXASIIL® group), to receive a 3-dose primary vaccination series followed by their booster doses, respectively. The safety and immunogenicity data collected up to 28 days following third vaccination i.e., Visit 7, shall be submitted to the regulatory authority. All subjects will be followed up further for booster dose. After Visit 7 (i.e., 28 days following completion of primary vaccination series) subjects will be followed up for safety every 3 months starting from the age of 6 months (i.e., at 6, 9, 12, 15, 18, and 21 months of age) until they receive the booster dose anytime between 12-24 months. There will be post booster follow up visit (EOS visit) 28 days after the booster immunization i.e., Visit 10 to assess the safety and post booster immunogenicity.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV | Experimental | Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPVHexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. |
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV | Active comparator | Biological: Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPVHexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants, as a 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female infants aged 6-8 weeks at the time of first vaccination.
- Infants with good health, as determined by the medical history, physical examination and clinical judgment of the Investigator.
- Informed consent form signed by at least one parent.
- Infants born at full term pregnancy (≥ 37 weeks).
- Infants with weight-for-length z-score ≥ -2 standard deviation (SD) at the time of enrolment.
Key exclusion criteria (17 listed)
- History of diphtheria/ tetanus/ pertussis/ hepatitis B/ Haemophilus Influenzae type b/ poliomyelitis infection(s).
- Presence of fever ≥ 38°C/ 100.4°F.
- Acute illness of moderate to severe intensity according to the clinical judgment of the investigator .
- Receipt of antibiotics in the past 3 days
- Previous vaccination or planned receipt of any vaccine against diphtheria, tetanus, pertussis, hepatitis B (except birth dose), poliomyelitis (except OPV birth dose) or Haemophilus Influenzae type b infection apart from trial vaccines during the study period.
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 |
|---|---|---|
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPVHexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. | Biological | Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV |
| Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPVHexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV for active immunization of infants as 3 dose regimen (6, 10 \& 14 weeks) for primary vaccination and booster dose at the age of 12-24 months. | Biological | Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV |
Primary outcome
Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine.
Time frame: 28 days post completion of 3-dose primary vaccination series in infants.
Percentage of infants achieving seroprotection for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b, poliovirus types 1, 2 \& 3, seroresponse for anti-B. pertussis and seroconversion for anti-pertussis toxin, 28 days post completion of a 3-dose primary vaccination series.
2 secondary outcomes
Assessment of occurrence, severity, and relationship of adverse events (AEs)
Time frame: Local and systemic solicited AEs occurring up to 7 days following each vaccination, unsolicited AEs and SAEs till 28 days post completion of a 3-dose primary vaccination series.
Assessment of immunogenicity of SIIPL reduced IPV hexavalent vaccine with the comparator vaccine, SIIPL HEXASIIL® and to assess lot-to-lot consistency among 3 lots of SIIPL reduced IPV Hexavalent vaccine
Time frame: 28 days post completion of the 3-dose primary vaccination series in infants.
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 1 Jul 2026.
- Individual participant dataSharing planned: Yes. Summary results for primary and secondary objectives
Related trials for Diptheria Immunization
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
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.
Anand Kawade principal investigator
KEM Hospital Research Centre, Pune, India
Sonali Palkar principal investigator
Bharati Vidyapeeth Medical College Hospital and Research Centre, Pune, India
M D Ravi principal investigator
JSS Hospitla, Mysore, India
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Reduced Dose IPV and Hexavalent (DTwP-HepB-IPV-Hib) Vaccine Containing Full Dose IPV in people with Diptheria Immunization and Tetanus Immunization, run by Serum Institute of India Pvt. Ltd. at 11 sites in 2 countries.
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 17 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in India, Bangladesh. 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?
Non-inferiority of SIIPL reduced IPV hexavalent vaccine in comparison with SIIPL HEXASIIL® vaccine. (time frame: 28 days post completion of 3-dose primary vaccination series in infants.). 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 1 Jul 2026; AzTrials last refreshed its copy on 7 Nov 2026.