A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 4, and 11 to 12 Months
Sponsor study identifier
Secondary identifiers
EUDRACT_NUMBER
OTHER · Merck
interventional
1,315
0 countries
N/A
Study Start
November 23, 2011
Actual (reported)Primary Completion
October 9, 2013
Actual (reported)Study Completion
October 9, 2013
Actual (reported)This study will determine whether participants who receive V419 (PR5I) at 2, 4, and 11 to 12 months of age have an acceptable response to the vaccine. This study will also determine whether the immune response to V419 is similar to that of participants who received a licensed vaccine control. The primary hypothesis is that participants who receive PR5I at 2, 4, and 11 to 12 months have an acceptable response rate to all PR5I-contained antigens at one month after the Toddler dose of PR5I.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 9, 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 23, 2011
Actual (reported)November 23, 2011
Actual (reported)November 28, 2011
Actual (reported)October 9, 2013
Actual (reported)October 9, 2013
Actual (reported)April 2, 2019
Actual (reported)Acceptability of Antibody (Ab) Response or Seroresponse Rates to All Antigens Contained in PR5I Vaccine One Month After the Toddler Dose of PR5I (11 to 12 Months of Age)
Acceptability response rates were defined as Ab titre ≥1.0 μg/mL for Haemophilus influenzae type b (Hib) (polyribosylribitol phosphate, PRP); ≥10 mIU/mL for Hepatitis (HBsAg); ≥0.1 IU/mL for diphtheria and tetanus; ≥8 (1/dil) for inactive poliovirus type (IPV) 1, 2 \& 3, and percentage of pertussis seroresponder participants (Pertussis toxoid \[PT\], Filamentous haemagglutinin \[FHA\], Fimbriae types 2 \& 3 \[FIM\] and Pertactin \[PRN\]) 1 month Post-Toddler dose of PR5I. Seroresponse was defined: (1) If pre-Dose 1 Ab concentration (cc) was \<LLOQ (lower limit of quantitation), postvaccination Ab cc was ≥LLOQ, (2) If pre-Dose 1 Ab cc was ≥LLOQ, postvaccination Ab cc was ≥prevaccination levels. Due to the timing of the occurrence of protocol violation or the availability of each antigen serology testing result, the analysis populations may not have been identical for each antigen-specific analysis at each post-vaccination visit.
1 month after Toddler dose of PR51 (post-toddler dose)
Infant series: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: PR5I 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
Infant series: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 2 and 4 months of age, and rotavirus vaccine (either Rotarix™ 1.5 mL oral dose at 2 and 4 months of age \[subset 1\] or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age \[subset 2\]). Toddler dose: INFANRIX™ hexa 0.5 mL injection + Prevenar 13™ 0.5 mL injection administered at 11 to 12 months of age.
DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis \[acellular, component\], hepatitis B \[recombinant DNA\], polio virus \[inactivated\], and Haemophilus influenza type b conjugate vaccine \[adsorbed\]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.
Silfverdal SA, Icardi G, Vesikari T, Flores SA, Pagnoni MF, Xu J, Liu GF, Stek JE, Boisnard F, Thomas S, Ziani E, Lee AW. A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months. Vaccine. 2016 Jul 19;34(33):3810-6. doi: 10.1016/j.vaccine.2016.05.054. Epub 2016 Jun 18.
Medical Director
Merck Sharp & Dohme LLC
1,315 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
November 23, 2011
Actual (reported)Immunogenicity and Safety of V419 (PR51) in Combination With MCC in Infants and Toddlers (V419-011)
Non-inferiority of Antibody (Ab) Response Rate to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa
1 month after the 2nd dose (post-infant dose 2)
Superiority of Antibody (Ab) Response Rates to Haemophilus Influenzae Type b (PRP) One Month After the 2nd Dose of PR5I (4 Months of Age) as Compared With INFANRIX Hexa
1 month after the 2nd dose (post-infant dose 2)
Non-inferiority Ab Response Rates to PR5I Antigens One Month After the Toddler Dose of PR5I (11 to 12 Months of Age) as Compared With INFANRIX Hexa
1 month after Toddler dose (post-toddler dose)
Non-inferiority of Rotavirus Response (Geometric Mean Titer, GMT) One Month After the 2nd Dose of Rotarix (4 Months of Age) Administered Concomitantly With PR5I Versus INFANRIX Hexa
1 month after the 2nd dose of Rotarix, administered concomitantly with PR5I or INFANRIX hexa (Post-Dose 2)
Number of Participants Who Experienced an Adverse Event (AE) From Day 1 to Day 15 After Any Vaccination
Solicited AEs: up to 5 days (Days 1-5 after any vaccination); unsolicited AEs: up to 15 days (Day 1-15 after any vaccination)
Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland)
Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.
Combined Diphtheria-Tetanus-acellular Pertussis \[DTaP\], Hepatitis B \[HepB\], Poliovirus \[IPV\] and Haemophilus influenzae type b \[Hib\] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
October 9, 2013
Actual (reported)Study Completion
October 9, 2013
Actual (reported)Last Updated
April 2, 2019
Results First Posted
April 2, 2019
Record last verified: 2019-03
http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf
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