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CompletedNCT02177032Updated Apr 7, 2017Results posted

Safety and Immunogenicity of Two Intradermal Rabies Vaccine Regimens Administered With and Without Human Rabies Immunoglobulin in Subjects ≥ 1 Years of Age

A Phase 3 interventional study of Rabies vaccine and Rabies vaccines + Rabies immunoglobulins in Rabies Infection, sponsored by Novartis. Completed at 6 sites in 2 countries. Open to participants aged 1 Year and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-04-07.

Sponsored by Novartis · Phase 3, Interventional, and Prevention

Phase
Phase 3
Study type
Interventional
Enrollment
885
Allocation
Randomized
Ages
1 Year and older
Sex
All
01

Study summary

Demonstrate non-inferiority of the immune response between new versus the currently recommended intradermal regimens of rabies vaccine when administered with or without rabies immunoglobulins in healthy subjects ≥ 1 years of age.

02

Conditions studied

  • Rabies Infection

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Keywords

  • Rabies vaccines
  • intradermal
  • human rabies immunoglobulins
03

In context

Rabies

118 studies on the registry are indexed under Rabies; 14 are open to participants now.

This study's enrollment of 885 is above the median of 200 across 108 interventional studies indexed under Rabies.

Browse Rabies studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  1. Healthy males and females ≥ 1 years of age
  2. Individuals/ individual's parents or legal guardians who have given written consent
  3. Individuals in good health
  4. Individuals who can comply with study procedures

Exclusion criteria

Exclusion Criteria:

  1. Behavioral or cognitive impairment or psychiatric disease.
  2. Unable to comprehend and to follow all required study procedures for the whole period of the study.
  3. History of illness or with an ongoing illness that may pose additional risk to the individual if he/she participates in the study.
  4. Individuals ≥ 1 to ≤ 17 years of age, who have or ever had a malignancy.
  5. Individuals ≥ 18 years of age, who have or who within the last 5 years, have had a malignancy (excluding nonmelanotic skin cancer) or lymphoproliferative disorder.
  6. Known or suspected impairment of the immune system (including but not limited to HIV, autoimmune disorders, immunosuppressive therapy as applicable).
  7. Female of childbearing potential who has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry.
  8. Female of childbearing potential, refusal to use an "acceptable birth control method" through day 50.
  9. Female of childbearing potential, with a positive pregnancy test prior to enrollment.
  10. Received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the previous 12 weeks.
  11. Allergic to any of the vaccine components.
  12. Allergic to any of the human rabies immunoglobulin components.
  13. Contraindication or precaution against rabies vaccination.
  14. Contraindication or precaution against man rabies immunoglobulin administration.
  15. Planning to receive anti-malaria medications (e.g. Mefloquine) 14 days prior to day 1 vaccination through day 50.
  16. Participating in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study at any time during the conduct of this study.
  17. Received any other vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who are planning to receive any vaccine within 28 days from the study vaccines.
  18. Body temperature ≥ 38.0°C (≥ 100.4°F) within 3 days of intended study vaccination.
  19. Received rabies vaccines or rabies immunoglobulin or have been exposed to rabies.
  20. Part of the study personnel or immediate family members of study personnel conducting this study.
  21. Current or history of drug or alcohol abuse within the past 2 years.
05

Study design

Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
885 participants (actual)

Study arms

  • Experimental
    4-sites, 1-week without HRIG

    PCEC rabies vaccine, administered ID according to the "4-sites, 1-week" regimen

    Biological: Rabies vaccine

  • Experimental
    4-sites, 1-week with HRIG

    PCEC rabies vaccine, administered ID to adults, according to the "4-sites, 1-week" regimen plus HRIG

    Biological: Rabies vaccines + Rabies immunoglobulins

  • Active comparator
    2-sites, TRC without HRIG

    PCEC rabies vaccine, administered ID according to the "2-sites, TRC" regimen

    Biological: Rabies vaccine

  • Active comparator
    2-sites, TRC with HRIG

    PCEC rabies vaccine, administered ID to adults , according to the "2-sites, TRC" regimen plus HRIG

    Biological: Rabies vaccines + Rabies immunoglobulins

Interventions

  • BiologicalRabies vaccine

    12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8).

  • BiologicalRabies vaccines + Rabies immunoglobulins

    12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the "4-sites, 1-week" regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

  • BiologicalRabies vaccine

    8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29).

  • BiologicalRabies vaccines + Rabies immunoglobulins

    8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the "2-sites, TRC", updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle.

06

What researchers measure

Primary outcomes

  1. Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)

    Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.

    Time frame: Study day 50 (D50)

Secondary outcomes

  1. Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs

    Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

    Time frame: Study Day 50

  2. Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age

    Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

    Time frame: At Days 8, 15, 91, 181 and 366

  3. Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age

    Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.

    Time frame: At Days 8, 15, 91, 181 and 366

  4. Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

    Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

    Time frame: At Days 8, 15, 50, 91, 181 and 366

  5. Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

    Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

    Time frame: At Days 8, 15,50, 91, 181 and 366

  6. Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age

    Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

    Time frame: At Days 8, 15, 50, 91, 181 and 366

  7. Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age

    Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

    Time frame: At Days 8, 15, 50, 91, 181 and 366

  8. Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

    Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

    Time frame: From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)

  9. Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)

    Time frame: Day 1 to Day 366

  10. Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

    Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

    Time frame: At Days 8, 15, 50, 91, 181 and 366

  11. Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

    Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

    Time frame: At Days 8, 15,50, 91, 181 and 366

07

Results

Posted Apr 7, 2017

Participant flow

Participant flow — Overall Study
Milestone4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIG
Started3558835488
Completed3508635188
Not completed5230
Withdrew: Administrative reason2010
Withdrew: Lost to follow-up0200
Withdrew: Other2010
Withdrew: Withdrawal by subject1010

Outcome measures

PrimaryPercentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)

Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. Non-inferiority of the immune response of the new "4-sites, 1-week" ID PEP regimen of the PCEC vaccine, with or without HRIG administration, to that of the currently recommended "2-sites, TRC" ID PEP regimen of the PCEC rabies vaccine with or without HRIG administration, as measured by the percentage of subjects with RVNA titer ≥ 0.5 IU/ml at day 50 in the whole study population.

Time frame:
Study day 50 (D50)
Reported as:
Number · Percentages of Subjects
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)
Percentages of SubjectsTOTAL 4-sites, 1-weekTOTAL 2-sites, TRC
Percentages of Subjects With RVNA Titer >= 0.5 and Vaccine Group Differences ("4-sites, 1-week" to That of "2-sites, TRC" ID PEP Regimen of the PCEC Rabies Vaccine With or Without HRIG Administration)99 (98 to 100)100 (99 to 100)
Statistical analysis
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: -1 · 95% CI -2.4 to 0
SecondaryGeometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs

Immunogenicity was assessed in terms of Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age at day 50 The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

Time frame:
Study Day 50
Reported as:
Geometric mean · IU/mL
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs
IU/mLTOTAL 4-sites, 1-weekTOTAL 2-sites, TRC
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Between-group (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC) With or Without HRIG) Ratio of GMCs4.58 (4.15 to 5.06)10 (9.29 to 11)
Statistical analysis
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 0.46 · 95% CI 0.37 to 0.58
SecondaryGeometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age The GMCs, GMRs (i.e., within group ratio) and associated two sided 95% confidence intervals for each group were computed by exponentiating (base 10) of the least square means of the logarithmically transformed (base 10) concentration (and their differences) and the 95% CIs obtained from an Analysis of variance (ANOVA) with vaccine regimen, age strata and center as factors. Non-inferiority of the immune response between the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC) with or without HRIG administration as measured by RVNA GMCs at day 50 in the whole study population.

Time frame:
At Days 8, 15, 91, 181 and 366
Reported as:
Geometric mean · IU/mL
Geometric Mean Rabies Virus Neutralizing Antibody Concentration at Days 8, 15, 91, 181 and 366 & Between-group (2 ID Rabies Vaccine Regimens (4-sites,1-week & 2-sites, TRC) With or Without HRIG) Ratio of GMCs in Children & Adult Subjects,≥ 1 Years of Age
IU/mLTOTAL 4-sites, 1-weekTOTAL 2-sites, TRC
Day 8 (N= 363, 362)0.23 (0.21 to 0.25)0.14 (0.13 to 0.15)
Day 15 (N= 357, 361)18 (17 to 20)12 (10 to 13)
Day 91 (N= 358, 362)2.32 (2.09 to 2.56)3.68 (3.32 to 4.07)
Day 181 (N= 357, 360)1.59 (1.41 to 1.78)1.44 (1.28 to 1.62)
Day 366 (N= 356, 352)1.59 (1.41 to 1.79)1.14 (1.01 to 1.28)
Statistical analysis
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 1.04 · 95% CI 0.84 to 1.29
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 1.68 · 95% CI 1.35 to 2.1
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 0.68 · 95% CI 0.54 to 0.85
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 1.22 · 95% CI 0.94 to 1.59
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · ANOVA · Vaccine group ratios: 1.67 · 95% CI 1.27 to 2.19
SecondaryPercentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age

Vaccine group differences are calculated assuming a binomial distribution and the associated confidence interval for the differences in percentage was based on M-N method. RVNA percentage of subjects with RVNA titer ≥ 0.5 IU/mL at study days 8, 15, 91, 181, and 366 following administration of the 2 ID rabies vaccine regimens (4-sites, 1-week and 2-sites, TRC), with or without HRIG, in the whole study population.

Time frame:
At Days 8, 15, 91, 181 and 366
Reported as:
Number · Percentages of Subjects
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL at Days 8, 15, 91, 181 and 366 in Children and Adult Subjects and Vaccine Group Differences (2 ID Rabies Vaccine Regimens (4-sites, 1-week and 2-sites, TRC), With or Without HRIG), ≥ 1 Years of Age
Percentages of SubjectsTOTAL 4-sites, 1-weekTOTAL 2-sites, TRC
Day 8 (N= 363, 362)18 (15 to 23)10 (7 to 13)
Day 15 (N= 357, 361)100 (99 to 100)100 (98 to 100)
Day 91 (N= 358, 362)96 (94 to 98)99 (98 to 100)
Day 181 (N= 357, 360)93 (90 to 95)93 (90 to 96)
Day 366 (N= 356, 352)90 (86 to 93)83 (79 to 87)
Statistical analysis
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: 9 · 95% CI 3.8 to 13.9
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: 0 · 95% CI -1 to 1.6
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: -3 · 95% CI -6 to -1.4
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: -1 · 95% CI -4.5 to 3.2
  • TOTAL 4-sites, 1-week vs TOTAL 2-sites, TRC · Fisher Exact · Protection rate differences: 6 · 95% CI 1.3 to 11.5
SecondaryGeometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. RVNA GMCs with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

Time frame:
At Days 8, 15, 50, 91, 181 and 366
Reported as:
Geometric mean · IU/mL
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
IU/mL4-sites, 1-week WITH HRIG4-sites, 1-week WITHOUT HRIG
Day 8 (N= 66, 150)0.21 (0.17 to 0.26)0.15 (0.13 to 0.17)
Day 15 (N= 65, 146)13 (11 to 15)15 (13 to 17)
Day 50 (N= 65, 146)1.97 (1.6 to 2.43)4.47 (3.9 to 5.13)
Day 91 (N= 65, 149)1.01 (0.81 to 1.27)2.28 (1.96 to 2.65)
Day 181 (N= 65, 146)0.88 (0.67 to 1.14)1.92 (1.61 to 2.29)
Day 366 (N= 65, 145)0.68 (0.53 to 0.88)1.42 (1.19 to 1.69)
Statistical analysis
  • 4-sites, 1-week WITH HRIG vs 4-sites, 1-week WITHOUT HRIG · Fisher Exact · Protection rate differences: -11 · 95% CI -19.6 to -1
  • 4-sites, 1-week WITH HRIG vs 4-sites, 1-week WITHOUT HRIG · Fisher Exact · Protection rate differences: 0 · 95% CI -5.6 to 2.6
  • 4-sites, 1-week WITH HRIG vs 4-sites, 1-week WITHOUT HRIG · Fisher Exact · Protection rate differences: -15 · 95% CI -26 to -7.1
  • 4-sites, 1-week WITH HRIG vs 4-sites, 1-week WITHOUT HRIG · Fisher Exact · Protection rate differences: -17 · 95% CI -29 to -7.1
  • 4-sites, 1-week WITH HRIG vs 4-sites, 1-week WITHOUT HRIG · Fisher Exact · Protection rate differences: -25 · 95% CI -37.8 to -13.2
SecondaryPercentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age. Percentage of subjects with RVNA titer ≥ 0.5 IU/mL at days 8, 15, 50, 91, 181 and 366 and group differences (4-sites,1-week without HRIG versus 4-sites,1-week with HRIG; 4-sites,1-week with HRIG versus 2-sites,TRC with HRIG; 4-sites,1-week without HRIG versus 2-sites, TRC without HRIG)

Time frame:
At Days 8, 15,50, 91, 181 and 366
Reported as:
Number · Percentages of Subjects
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Percentages of Subjects4-sites, 1-week WITH HRIG4-sites, 1-week WITHOUT HRIG
Day 1 (N= 66, 151)0 (0 to 5)0 (0 to 2)
Day 8 (N= 66, 150)8 (3 to 17)19 (13 to 26)
Day 15 (N= 65, 146)100 (94 to 100)100 (98 to 100)
Day 50 (N= 65, 146)95 (87 to 99)100 (98 to 100)
Day 91 (N= 65, 149)83 (72 to 91)98 (94 to 100)
Day 181 (N= 65, 146)77 (65 to 86)94 (89 to 97)
Day 366 (N= 65, 145)66 (53 to 77)91 (85 to 95)
SecondaryGeometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

Time frame:
At Days 8, 15, 50, 91, 181 and 366
Reported as:
Geometric mean · IU/mL
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration in Children and Adult Subjects, ≥ 1 Years of Age
IU/mL4-sites, 1-week Without HRIG2-sites, TRC Without HRIG
Day 1 (N=298, 290)0.05 (0.05 to 0.05)0.05 (0.05 to 0.05)
Day 8 (N= 297, 290)0.23 (0.21 to 0.25)0.13 (0.12 to 0.14)
Day 15 (N= 292, 289)19 (17 to 21)12 (11 to 13)
Day 50 (N= 292, 281)5.04 (4.56 to 5.57)10 (9.48 to 12)
Day 91 (N= 293, 290)2.54 (2.29 to 2.82)3.8 (3.42 to 4.21)
Day 181 (N= 292, 289)1.73 (1.53 to 1.95)1.5 (1.32 to 1.69)
Day 366 (N= 291, 283)1.73 (1.53 to 1.95)1.2 (1.06 to 1.36)
SecondaryPercentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age

Immunogenicity was assessed in terms of the Percentages of Subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Children and Adult Subjects, ≥ 1 Years of Age

Time frame:
At Days 8, 15, 50, 91, 181 and 366
Reported as:
Number · Percentages of Subjects
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Children and Adult Subjects, ≥ 1 Years of Age
Percentages of Subjects4-sites, 1-week Without HRIG2-sites, TRC Without HRIG
Day 8 (N= 297, 290)21 (16 to 26)10 (7 to 14)
Day 15 (N= 292, 289)100 (99 to 100)100 (99 to 100)
Day 50 (N= 292, 281)100 (99 to 100)100 (99 to 100)
Day 91 (N= 293, 290)99 (97 to 100)100 (98 to 100)
Day 181 (N= 292, 289)96 (93 to 98)96 (92 to 98)
Day 366 (N= 291, 283)95 (92 to 97)87 (82 to 90)
SecondaryNumber of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

Number of subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

Time frame:
From day 1 to day 3; from day 4 to day 7; from day 8 to day 14; from day 29 to day 35(2-sites, TRC PEP, ID regimen)
Reported as:
Number · Subjects
Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Subjects4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIG
Injection site erythema(≥ 1 to ≤ 5 Y); Day 10NA0NA
Injection site erythema(≥ 1 to ≤ 5 Y); Day 40NA0NA
Injection site erythema(≥ 1 to ≤ 5 Y); Day 81NA0NA
Injection site erythema(≥ 1 to ≤ 5 Y); Day 29NANA2NA
Injection site induration(≥ 1 to ≤ 5 Y); Day 10NA0NA
Injection site induration(≥ 1 to ≤ 5 Y); Day 40NA0NA
Injection site induration(≥ 1 to ≤ 5 Y); Day 80NA0NA
Injection site induration(≥ 1 to ≤ 5 Y); Day 29NANA1NA
Injection site swelling (≥ 1 to ≤ 5 Y); Day 10NA0NA
Injection site swelling (≥ 1 to ≤ 5 Y); Day 40NA0NA
Injection site swelling (≥ 1 to ≤ 5 Y); Day 80NA2NA
Injection site swelling (≥ 1 to ≤ 5 Y); Day 29NANA8NA
Injection site erythema (≥ 6 to ≤ 17 Y); Day 10NA0NA
Injection site erythema (≥ 6 to ≤ 17 Y); Day 40NA0NA
Injection site erythema (≥ 6 to ≤ 17 Y); Day 81NA2NA
Injection site erythema (≥ 6 to ≤ 17 Y); Day 29NANA8NA
Injection site induration (≥ 6 to ≤ 17 Y); Day 10NA0NA
Injection site induration (≥ 6 to ≤ 17 Y); Day 41NA0NA
Injection site induration (≥ 6 to ≤ 17 Y); Day 80NA1NA
Injection site induration (≥ 6 to ≤ 17 Y); Day 29NANA2NA
Injection site swelling (≥ 6 to ≤ 17 Y); Day 10NA0NA
Injection site swelling (≥ 6 to ≤ 17 Y); Day 41NA0NA
Injection site swelling (≥ 6 to ≤ 17 Y); Day 80NA2NA
Injection site swelling (≥ 6 to ≤ 17 Y); Day 29NANA2NA
Injection site erythema (≥ 18 Y); Day 13623
Injection site erythema (≥ 18 Y); Day 411445
Injection site erythema (≥ 18 Y); Day 812184
Injection site erythema (≥ 18 Y); Day 29NANA2713
Injection site induration (≥ 18 Y); Day 10000
Injection site induration (≥ 18 Y); Day 40000
Injection site induration (≥ 18 Y); Day 82020
Injection site induration (≥ 18 Y); Day 29NANA41
Injection site swelling (≥ 18 Y); Day 10010
Injection site swelling (≥ 18 Y); Day 40000
Injection site swelling (≥ 18 Y); Day 80020
Injection site swelling (≥ 18 Y); Day 29NANA51
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 14NA3NA
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 43NA1NA
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 83NA2NA
Change In Eating Habits,( ≥ 1 to ≤ 5 Y); Day 29NANA6NA
Sleepiness (≥ 1 to ≤ 5 Y); Day 14NA7NA
Sleepiness (≥ 1 to ≤ 5 Y); Day 47NA3NA
Sleepiness (≥ 1 to ≤ 5 Y); Day 82NA4NA
Sleepiness (≥ 1 to ≤ 5 Y); Day 29NANA2NA
Vomiting (≥ 1 to ≤ 5 Y); Day 14NA1NA
Vomiting (≥ 1 to ≤ 5 Y); Day 42NA1NA
Vomiting (≥ 1 to ≤ 5 Y); Day 81NA0NA
Vomiting (≥ 1 to ≤ 5 Y); Day 29NANA5NA
Diarrhea (≥ 1 to ≤ 5 Y); Day 13NA2NA
Diarrhea (≥ 1 to ≤ 5 Y); Day 42NA2NA
Diarrhea (≥ 1 to ≤ 5 Y); Day 84NA1NA
Diarrhea (≥ 1 to ≤ 5 Y); Day 29NANA4NA
Irritability.( ≥ 1 to ≤ 5 Y); Day 15NA3NA
Irritability.( ≥ 1 to ≤ 5 Y); Day 43NA3NA
Irritability.( ≥ 1 to ≤ 5 Y); Day 81NA5NA
Irritability.( ≥ 1 to ≤ 5 Y); Day 29NANA5NA
Chills(≥ 6 to ≤ 17 Y); Day 12NA2NA
Chills(≥ 6 to ≤ 17 Y); Day 40NA1NA
Chills(≥ 6 to ≤ 17 Y); Day 81NA1NA
Chills(≥ 6 to ≤ 17 Y); Day 29NANA0NA
Nausea ( ≥ 6 to ≤ 17 Y); Day 14NA3NA
Nausea ( ≥ 6 to ≤ 17 Y); Day 42NA1NA
Nausea ( ≥ 6 to ≤ 17 Y); Day 83NA1NA
Nausea ( ≥ 6 to ≤ 17 Y); Day 29NANA0NA
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 15NA1NA
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 44NA2NA
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 82NA3NA
Generalized Myalgia (≥ 6 to ≤ 17 Y); Day 29NANA4NA
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 13NA1NA
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 41NA1NA
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 84NA2NA
Generalized Arthralgia (≥ 6 to ≤ 17 Y); Day 29NANA1NA
Headache (≥ 6 to ≤ 17 Y); Day 18NA9NA
Headache (≥ 6 to ≤ 17 Y); Day 48NA8NA
Headache (≥ 6 to ≤ 17 Y); Day 86NA6NA
Headache (≥ 6 to ≤ 17 Y); Day 29NANA3NA
Fatigue (≥ 6 to ≤ 17 Y); Day 18NA7NA
Fatigue (≥ 6 to ≤ 17 Y); Day 45NA1NA
Fatigue (≥ 6 to ≤ 17 Y); Day 81NA6NA
Fatigue (≥ 6 to ≤ 17 Y); Day 29NANA6NA
Rash (≥ 6 to ≤ 17 Y); Day 14NA0NA
Rash (≥ 6 to ≤ 17 Y); Day 43NA3NA
Rash (≥ 6 to ≤ 17 Y); Day 83NA3NA
Rash (≥ 6 to ≤ 17 Y); Day 29NANA2NA
Vomitting (≥ 6 to ≤ 17 Y); Day 13NA5NA
Vomitting (≥ 6 to ≤ 17 Y); Day 42NA1NA
Vomitting (≥ 6 to ≤ 17 Y); Day 83NA2NA
Vomitting (≥ 6 to ≤ 17 Y); Day 29NANA1NA
Diarrhea (≥ 6 to ≤ 17 Y); Day 14NA2NA
Diarrhea (≥ 6 to ≤ 17 Y); Day 40NA1NA
Diarrhea (≥ 6 to ≤ 17 Y); Day 81NA0NA
Diarrhea (≥ 6 to ≤ 17 Y); Day 29NANA0NA
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 16NA3NA
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 43NA1NA
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 81NA1NA
Loss Of Appetite (≥ 6 to ≤ 17 Y); Day 29NANA0NA
Chills (≥ 18 Y); Day 18352
Chills (≥ 18 Y); Day 41264
Chills (≥ 18 Y); Day 85040
Chills (≥ 18 Y); Day 29NANA00
Nausea,( ≥ 18 Y); Day 18333
Nausea,( ≥ 18 Y); Day 44223
Nausea,( ≥ 18 Y); Day 84043
Nausea,( ≥ 18 Y); Day 29NANA00
Generalized Myalgia (≥ 18 Y); Day 123121912
Generalized Myalgia (≥ 18 Y); Day 4167126
Generalized Myalgia (≥ 18 Y); Day 8205159
Generalized Myalgia (≥ 18 Y); Day 29NANA74
Generalized Arthralgia (≥ 18 Y); Day 1187137
Generalized Arthralgia (≥ 18 Y); Day 465107
Generalized Arthralgia (≥ 18 Y); Day 8153156
Generalized Arthralgia (≥ 18 Y); Day 29NANA64
Headache (≥ 18 Y); Day 12461113
Headache (≥ 18 Y); Day 414101511
Headache (≥ 18 Y); Day 81981516
Headache (≥ 18 Y); Day 29NANA1211
Fatigue (≥ 18 Y); Day 128111910
Fatigue (≥ 18 Y); Day 42161711
Fatigue (≥ 18 Y); Day 81981514
Fatigue (≥ 18 Y); Day 29NANA910
Rash (≥ 18 Y); Day 110340
Rash (≥ 18 Y); Day 44384
Rash (≥ 18 Y); Day 864112
Rash (≥ 18 Y); Day 29NANA22
Vomitting (≥ 18 Y); Day 10020
Vomitting (≥ 18 Y); Day 40111
Vomitting (≥ 18 Y); Day 81013
Vomitting (≥ 18 Y); Day 29NANA10
Diarrhea (≥ 18 Y); Day 15425
Diarrhea (≥ 18 Y); Day 43253
Diarrhea (≥ 18 Y); Day 85144
Diarrhea (≥ 18 Y); Day 29NANA30
Loss Of Appetite (≥ 18 Y); Day 17052
Loss Of Appetite (≥ 18 Y); Day 43220
Loss Of Appetite (≥ 18 Y); Day 83324
Loss Of Appetite (≥ 18 Y); Day 29NANA11
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 115NA8NA
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 48NA9NA
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 87NA8NA
Injection site tenderness (≥ 1 to ≤ 5 Y); Day 29NANA9NA
Injection site pain (≥ 6 to ≤ 17 Y); Day 114NA7NA
Injection site pain (≥ 6 to ≤ 17 Y); Day 46NA10NA
Injection site pain (≥ 6 to ≤ 17 Y); Day 86NA11NA
Injection site pain (≥ 6 to ≤ 17 Y); Day 29NANA6NA
Injection site pain (≥ 18 Y); Day 11261611
Injection site pain (≥ 18 Y); Day 488133
Injection site pain (≥ 18 Y); Day 887213
Injection site pain (≥ 18 Y); Day 29NANA149
SecondaryNumber of Subjects Reporting Unsolicited Adverse Events (AEs)

Safety was assessed in terms of the Number of Subjects Reporting Unsolicited Adverse Events (AEs)

Time frame:
Day 1 to Day 366
Reported as:
Number · Subjects
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Subjects4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIG
≥ 1 to ≤ 5 Y Any AEs;D1-36645NA53NA
≥ 1 to ≤ 5 Y SAE;D1-3663NA4NA
≥ 1 to ≤ 5 Y At least possibly related SAEs;D1-3660NA0NA
≥ 1 to ≤ 5 Y Deaths;D1-3660NA0NA
≥1 to ≤ 5 Y Withdrawal from study due to AE;D1-3660NA0NA
≥ 6 to ≤ 17 Y Any AEs;D1-36658NA711
≥ 6 to ≤ 17 Y SAE;D1-3661NA3NA
≥6 to ≤ 17 Y At least possibly related SAEs;D1-3660NA0NA
≥ 6 to ≤ 17 Y Deaths;D1-3660NA0NA
≥6 to ≤17 Y Withdrawal from study due to AE;D1-3660NA0NA
≥ 18 Y Any AEs;D1-3661577115672
≥ 18 Y SAE;D1-3668375
≥ 18 Y At least possibly related SAEs;D1-3660000
≥ 18 Y Deaths;D1-3660000
≥ 18 Y Withdrawal from study due to AE;D1-3660000
Overall population ≥ 1 Y Any AEs;D1-3662607128073
Overall population ≥ 1 Y SAE;D1-366123145
Overall ≥1Y Atleast possibly related SAEs;D1-3660000
Overall population ≥ 1 Y Deaths;D1-3660000
Overall population ≥1Y Withdrawal due to AE;D1-3660000
SecondaryGeometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL at Days 8, 15, 50,91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

Time frame:
At Days 8, 15, 50, 91, 181 and 366
Reported as:
Geometric mean · IU/mL
Geometric Mean Rabies Virus Neutralizing Antibody (RVNA) Concentration ≥0.5 IU/mL and Vaccine Group Differences in Adult Subjects, ≥ 18 Years of Age
IU/mL4-sites, 1-week WITH HRIG2-sites TRC WITH HRIG
Day 1 (N= 66, 72)0.05 (0.05 to 0.05)0.05 (0.05 to 0.05)
Day 8 (N= 66, 72)0.21 (0.17 to 0.26)0.17 (0.14 to 0.21)
Day 15 (N= 65, 72)13 (11 to 15)8.37 (6.96 to 10)
Day 50 (N= 65, 69)1.97 (1.6 to 2.43)6.37 (5.21 to 7.78)
Day 91 (N= 65, 72)1.01 (0.81 to 1.27)2.25 (1.81 to 2.79)
Day 181 (N= 65, 71)0.88 (0.67 to 1.14)1.05 (0.81 to 1.35)
Day 366 (N= 65, 69)0.68 (0.53 to 0.88)0.59 (0.46 to 0.76)
SecondaryPercentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age

Immunogenicity was assessed in terms of the number of subjects With Anti-RVNA concentration ≥0.5 IU/mL at Days 8, 15, 50, 91, 181 and 366 in Adult Subjects, ≥ 18 Years of Age

Time frame:
At Days 8, 15,50, 91, 181 and 366
Reported as:
Number · Percentages of Subjects
Percentages of Subjects With Anti-RVNA Titer ≥0.5 IU/mL in Adult Subjects, ≥ 18 Years of Age
Percentages of Subjects4-sites, 1-week WITH HRIG2-sites, TRC WITH HRIG
Day 1 (N= 66, 72)0 (0 to 5)0 (0 to 5)
Day 8 (N= 66, 72)8 (3 to 17)10 (4 to 19)
Day 15 (N= 65, 72)100 (94 to 100)99 (93 to 100)
Day 50 (N= 65, 69)95 (87 to 99)100 (95 to 100)
Day 91 (N= 65, 72)83 (72 to 91)99 (93 to 100)
Day 181 (N= 65, 71)77 (65 to 86)85 (74 to 92)
Day 366 (N= 65, 69)66 (53 to 77)70 (57 to 80)

Adverse events

Collected over Day 1 to day 366 (Study Groups: A1- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen without HRIG, A2- 4-sites, 1-week" (4-4-4-0-0) ID PEP regimen with HRIG, B1- 2-sites TRC" (2-2-2-0-2) ID PEP regimen without HRIG, B2- 2-sites TRC" (2-2-2-0-2) ID PEP regimen with HRIG).. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
4-sites, 1-week WITHOUT HRIG—5/356 (1.4%)292/356 (82%)
4-sites, 1-week WITH HRIG—1/85 (1.2%)78/85 (91.8%)
2-sites, TRC WITHOUT HRIG—4/353 (1.1%)298/353 (84.4%)
2-sites, TRC WITH HRIG—2/89 (2.2%)82/89 (92.1%)
Most frequent serious events
Showing 10 of 22
Most frequent serious events
Event4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIG
Animal BiteInjury, poisoning and procedural complications5/3560/854/3532/89
Appendiceal AbscessInfections and infestations0/3561/850/3530/89
Dengue FeverInfections and infestations1/3561/851/3530/89
TonsillitisInfections and infestations0/3561/851/3530/89
Angina UnstableCardiac disorders0/3560/850/3531/89
Urinary Tract InfectionInfections and infestations0/3560/850/3531/89
Animal ScratchInjury, poisoning and procedural complications1/3560/852/3531/89
Irritable Bowel SyndromeGastrointestinal disorders0/3560/851/3530/89
GastroenteritisInfections and infestations0/3560/851/3530/89
Hand-Foot-And-Mouth DiseaseInfections and infestations0/3560/851/3530/89
Most frequent other events
Showing 10 of 20
Most frequent other events
Event4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIG
INJECTION SITE ERYTHEMAGeneral disorders195/35659/85168/35356/89
HEADACHENervous system disorders53/35621/8554/35331/89
FATIGUEGeneral disorders53/35616/8552/35324/89
VACCINATION SITE ERYTHEMAGeneral disorders82/35619/8579/35323/89
INJECTION SITE PAINGeneral disorders77/35618/8589/35320/89
MYALGIAMusculoskeletal and connective tissue disorders45/35619/8541/35319/89
ARTHRALGIAMusculoskeletal and connective tissue disorders33/3569/8533/35317/89
INJECTION SITE INDURATIONGeneral disorders52/35613/8562/35313/89
INJECTION SITE SWELLINGGeneral disorders39/3568/8547/3534/89
DIARRHOEAGastrointestinal disorders28/3568/8520/3538/89

Baseline characteristics

Age, Continuous
Age, Continuous(year)4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIGTotal
Mean20.0 ± 15.032.7 ± 10.820.6 ± 15.134.4 ± 11.222.9 ± 15.3
Sex: Female, Male
Sex: Female, Male(Participants)4-sites, 1-week WITHOUT HRIG4-sites, 1-week WITH HRIG2-sites, TRC WITHOUT HRIG2-sites, TRC WITH HRIGTotal
FEMALE2024417951476
MALE1534417537409
08

Study locations

6 sites
  • 4, De La Salle Health Sciences Institute
    Cavite, 4114, Philippines
  • 1, Research Institute for Tropical Medicine
    Muntinlupa, 1781, Philippines
  • 2, Asian Hospital and Medical Center
    Muntinlupa, 1781, Philippines
  • 3, Research Institute for Tropical Medicine
    Muntinlupa, Philippines
  • 11, Infectious Diseases Unit, Department of Pediatrics, Phramongkutklao hospital
    Bangkok, 10400, Thailand
  • 12, Department of Tropical Pediatrics, Faculty of Tropical Medicine, Mahidol University
    Bangkok, 10400, Thailand
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02177032
Lead sponsor
Novartis
Collaborators
Novartis Vaccines
Responsible party
Sponsor
First posted
Jun 27, 2014
Start date
Jun 2014
Primary completion
Oct 2014
Completion
Aug 2015
Results posted
Apr 7, 2017
Last update
Apr 7, 2017

Study contacts

Novartis Vaccines
study chair · Novartis Vaccines

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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