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Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months (VIPV-06)

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ClinicalTrials.gov Identifier: NCT03032419
Recruitment Status : Completed
First Posted : January 26, 2017
Last Update Posted : November 14, 2018
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Larix A/S
Syneos Health
AJ Vaccines
Information provided by (Responsible Party):
Statens Serum Institut

Brief Summary:
The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)

Condition or disease Intervention/treatment Phase
Poliomyelitis Biological: IPV-Al SSI Biological: IPV SSI Phase 3

Detailed Description:

In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:

Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.

2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.

Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood sample is taken for polio antibody measurements, contraindications are reviewed, the 4th vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.

Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded. The end of trial form is completed.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1002 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 6, 10, 14 Weeks and 9 Months of Age
Actual Study Start Date : February 6, 2017
Actual Primary Completion Date : September 21, 2017
Actual Study Completion Date : March 12, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPV-Al SSI
IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
Biological: IPV-Al SSI
3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age

Active Comparator: IPV SSI
IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age
Biological: IPV SSI
3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
Other Name: IPV Vaccine SSI




Primary Outcome Measures :
  1. Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI [ Time Frame: Change from baseline to one month after 3rd vaccination ]

Secondary Outcome Measures :
  1. Adverse event following vaccinations (key secondary) [ Time Frame: After primary injections at 2, 4 and 6 months of age ]
  2. Subjects with seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: One months after 3rd vaccination ]
  3. Subjects with seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after the 4th vaccination ]
  4. Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody [ Time Frame: One months after 3rd vaccination ]
  5. Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3 [ Time Frame: One months after 3rd vaccination ]
  6. Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after the 4th vaccination ]
  7. Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 [ Time Frame: From baseline, one month after 3rd vaccination, and before and one month after 4th vaccination ]

Other Outcome Measures:
  1. Sensitivity analysis: subjects with ≥ 4-fold increases in poliovirus types 1, 2 and 3 titres [ Time Frame: From baseline to one month after 3rd vaccination ]
  2. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: One month after 3rd vaccinations ]
  3. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - seroprotection against poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after 4th vaccination ]
  4. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - post-vaccination titre ≥ 4-fold above maternal titre against poliovirus types 1, 2 and 3 [ Time Frame: One month after 3th vaccination ]
  5. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3 [ Time Frame: One month after 3th vaccination ]
  6. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - geometric mean titres and median for poliovirus types 1, 2 and 3 [ Time Frame: Before and one month after 4th vaccination ]
  7. Sensitivity analysis: sub-groups of infants with and without seroprotection at baseline - reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3 [ Time Frame: From baseline to one month after 4th vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
  2. Healthy assessed from medical history and physical examination
  3. Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
  4. Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
  5. Parent(s)/guardian(s) granting access to the infant's trial related medical records
  6. Parent(s)/guardian(s) likely to comply with the trial procedures

Exclusion Criteria:

  1. Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
  2. OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial
  3. Low birth weight (< 2,500 g)
  4. Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
  5. Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
  6. Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
  7. Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
  8. Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial
  9. Participating in another clinical trial
  10. Not suitable for inclusion in the opinion of the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03032419


Locations
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Philippines
5 sites in Philippines
Manila, Philippines
Sponsors and Collaborators
Statens Serum Institut
Bill and Melinda Gates Foundation
Larix A/S
Syneos Health
AJ Vaccines
Investigators
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Study Director: Ingrid Kromann Statens Serum Institut

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Responsible Party: Statens Serum Institut
ClinicalTrials.gov Identifier: NCT03032419     History of Changes
Other Study ID Numbers: VIPV-06
First Posted: January 26, 2017    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Poliomyelitis
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs