Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants

This study has been completed.
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Pauline Verdijk, Institute of Public Health and the Environment
ClinicalTrials.gov Identifier:
NCT01709071
First received: October 16, 2012
Last updated: February 20, 2014
Last verified: February 2014

October 16, 2012
February 20, 2014
February 2012
November 2012   (final data collection date for primary outcome measure)
Number of adverse reactions following vaccination [ Time Frame: 5 days or until adverse reactions have resolved ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01709071 on ClinicalTrials.gov Archive Site
Level of virus neutralizing titers in serum [ Time Frame: 28 days after last vaccination ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Immunogenicity of a New Inactivated Poliovirus Vaccine in Infants
Double Blind Dose - Escalation, Randomized, Controlled, Phase I-II Trial to Evaluate Safety and Immunogenicity of Three Doses of Sabin-IPV and Adjuvanted Sabin-IPV in Healthy Infants

A new inactivated polio vaccine based on attenuated poliovirus strains was developed to transfer the technology to manufacturers in low- and middle-income countries. This vaccine was produced in different dosages and in different formulations. In healthy adults the safety of the highest dose was comparable to that of the existing inactivated polio vaccine. The purpose of this trial is to determine the safety of the different dosages and formulations of the vaccine in infants. The second goal of this study is to analyse the immune response after three doses in infants.

The goal of this study is to assess the safety and immunogenicity of Sabin-IPV and adjuvanted Sabin-IPV produced with the production process set up for technology transfer by the National Institute for Public Health and the Environment (RIVM, formerly the Netherlands Vaccine Institute (NVI).

  • The primary objective is to evaluate safety (local and systemic reactions) of intramuscular injection with Sabin-IPV and adjuvanted Sabin-IPV in healthy infants.
  • The secondary objective is to evaluate immunogenicity of three doses Sabin-IPV and adjuvanted Sabin-IPV in infants.
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Poliomyelitis
  • Drug: IPV
    Other Names:
    • IPV (NVI)
    • Inactivated poliomyelitis vaccine
    • Inactivated poliovirus vaccine
    • Inactivated polio vaccine
  • Drug: Low dose Sabin-IPV
  • Drug: Low dose adjuvanted Sabin-IPV
  • Drug: Middle dose Sabin-IPV
  • Drug: Middle dose adjuvanted Sabin-IPV
  • Drug: High dose Sabin-IPV
  • Drug: High dose adjuvanted Sabin-IPV
  • Experimental: Low dose Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: Low dose Sabin-IPV
  • Experimental: Low dose adjuvanted Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 2.5, 4, 8 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: Low dose adjuvanted Sabin-IPV
  • Experimental: Middle dose Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: Middle dose Sabin-IPV
  • Experimental: Middle dose adjuvanted Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 5, 8, 16 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: Middle dose adjuvanted Sabin-IPV
  • Experimental: High dose Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 20, 32, 64 D-antigen units respectively of Sabin-1,-2 and -3 per dose.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: High dose Sabin-IPV
  • Experimental: High dose adjuvanted Sabin-IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 10, 16, 32 D-antigen units respectively of Sabin-1,-2 and -3 per dose adjuvanted with 0.5 mg aluminium hydroxide.

    Infants receive three vaccinations with an interval of 8 weeks between doses.

    Intervention: Drug: High dose adjuvanted Sabin-IPV
  • Active Comparator: Conventional IPV

    Intramuscular injection of 0.5 ml of Inactivated Poliomyelitis Vaccine containing 40, 8, and 32 D-antigen units respectively of Mahoney, MEF-1 and Saukett poliovirus per dose.

    Infants receive three injections with an interval of 8 weeks between doses.

    Intervention: Drug: IPV

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
May 2013
November 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age 8 weeks (56-63 days) at the time of first vaccination
  • Infants in good general health, eligible to be vaccinated according to the Polish national vaccination program. The same health criteria apply as used in well-baby clinics when a child receives a vaccination, e.g. also children with a small increase in temperature (< 38.5° C) or with a common cold (runny nose etc) are seen as children with normal health.
  • The parent(s)/legally representative(s) have to be willing and able to allow their child to participate in the trial according to the described procedures
  • Presence of a signed informed consent in which the parent(s)/legally representative(s) have given written informed consent after receiving oral and written information (signature from one parent in case of single-parent family).

Exclusion Criteria:

  • Any IPV or OPV dose
  • Known or suspected allergy against any of the vaccine components
  • History of unusual or severe reactions to any previous vaccination administration of plasma (including immunoglobulins) or blood products prior and during the study
  • Any vaccination less than 14 days before or after each vaccination with the IMP
  • History of any neurological disorder including epilepsy or febrile seizures
  • Any infectious disease at the time of screening and/or inclusion that might interfere with the results of the study
  • Present evidence of serious disease(s) demanding immunosuppressive medical treatment, like cytostatics and prednisolones, that might interfere with the results of the study
  • Any known or suspected primary or secondary immunodeficiency
  • Communication problems interfering in the study realization according to the judgment of the investigator
  • Bleeding disorders and use of anticoagulants
  • Premature birth (<37 weeks)
  • Participation in another clinical trial
Both
56 Days to 63 Days
Yes
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01709071
NVI-256B, 2011-003792-11
Yes
Pauline Verdijk, Institute of Public Health and the Environment
Pauline Verdijk
World Health Organization
Study Director: Pauline Verdijk, PhD National Institute for Public Health and the Environment (RIVM)
National Institute for Public Health and the Environment (RIVM)
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP