Diarrhea, Diarrhea Rotavirus
Conditions
Keywords
diarrhea, Rotavirus, ROTAVAC, Rotavirus vaccine
Brief summary
The study is being conducted to evaluate and compare the immunogenicity of ROTAVAC® and ROTAVAC 5D 28 days after the last dose of the vaccine, when administered to infants in a three-dose schedule at 6, 10 and 14 weeks of age. The study will also assess the reactogenicity of the vaccine 7 days after each vaccination and safety from first vaccination up to 4 weeks after the last vaccination with ROTAVAC® and ROTAVAC 5D, and of Rotarix® when administered to infants in a two-dose schedule at 6 and 10 weeks of age.
Detailed description
This study is designed as a Phase IIb, single center, randomized, controlled, open label study with 3 groups of infants (n=150 per group) receiving either three doses of ROTAVAC® three doses of ROTAVAC 5D or two doses of Rotarix®. 450 participants will be randomized (1:1:1) to receive ROTAVAC®, ROTAVAC 5D or Rotarix®. The three doses of ROTAVAC® and ROTAVAC 5D will be administered at 6, 10 and 14 weeks of age whereas two doses of Rotarix® will be administered at 6 and 10 weeks of age. All vaccines will be administered concomitantly with EPI vaccines including Diphtheria, Tetanus, Pertussis, Haemophilus influenzae type b and Hepatitis B vaccine (DTwP-Hib-HepB), Pneumococcal conjugate vaccine and OPV at 6, 10 and 14 weeks and IPV at week 14 (when switched to in Zambia). The participants will be monitored for 30 minutes following vaccine administration for immediate adverse events. A blood sample will be obtained from all the participating infants before first vaccination and four weeks after the last vaccine dose. This would mean that the blood sample will be collected at approximately 14 weeks of age for infants in the Rotarix® arm and 18 weeks for infants in the ROTAVAC® groups. Enhanced passive/Active surveillance for vaccine reactogenicity (solicited reactions) over the 7-day period after each vaccination will be conducted on all infants. In addition, surveillance for unsolicited AEs, SAEs including intussusception will be carried out over the period between first vaccination and four weeks after the last vaccination on all infants. The study will compare the immunogenicity of the two formulations of ROTAVAC® i.e. ROTAVAC® vs. ROTAVAC 5D and will descriptively analyze the immune response to Rotarix®. Primary immunogenicity analysis of all samples will be based on a validated ELISA which uses strain WC3 as a substrate. A subset of the samples (50 pairs/arms) collected will also be tested by a validated ELISA which uses strain 89-12 (G1P8 virus) as a substrate. This trial will generate immunogenicity and safety data on ROTAVAC® and ROTAVAC 5D outside of India. Presentation of data to Zambian Ministry of Health, WHO and in peer reviewed open access publications will be key audiences targeted for communication of results.
Interventions
BIOLOGICALROTAVAC®
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
BIOLOGICALROTAVAC 5D
0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
BIOLOGICALRotarix®
1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.
Sponsors
PATH
Christian Medical College, Vellore, India
Children's Hospital Medical Center, Cincinnati
Bharat Biotech International Limited
Centre for Infectious Disease Research in Zambia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Phase IIb, single center, randomized, controlled, open label study
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. Healthy infant as established by medical history and clinical examination before entering the study. 2. Age: 6-8 weeks (42-56 days, both days inclusive) confirmed by Immunization Record. 3. Infants received age-appropriate EPI vaccines till enrolment. 4. Ability and willingness to provide informed consent as per local consenting procedures. 5. Parent can be contacted on phone and confirms intention to remain in the study area with the participant during the study period.
Exclusion criteria
1. Presence of diarrhea or vomiting in the previous 72 hours or on the day of enrolment (temporary exclusion). 2. Presence of fever on the day of enrolment (temporary exclusion). 3. Acute disease at the time of enrolment (temporary exclusion). 4. Concurrent participation in another clinical trial throughout the entire timeframe of this study. 5. Presence of severe malnutrition (weight-for-height z-score \< -3SD median). 6. Any systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol. 7. History of congenital abdominal disorders, intussusception, abdominal surgery 8. Known or suspected impairment of immunological function based on medical history and physical examination. 9. Prior receipt or intent to receive rotavirus and other age specified EPI vaccines outside of the study center and during study participation. 10. A known sensitivity or allergy to any component of the study vaccine. 11. Clinically detectable significant congenital or genetic defect. 12. History of persistent diarrhea (defined as diarrhea more than 14 days). 13. Participant's parents not able, available or willing to accept active follow-up by the study staff. 14. Has received any immunoglobulin therapy and/or blood products since birth or planned administration during the study period. 15. History of chronic administration (defined as more than 14 days) of immunosuppressants including corticosteroids. Infants on inhaled or topical steroids may be permitted to participate in the study. 16. History of any neurologic disorders or seizures. 17. Any medical condition in the parents/infants that, in the judgment of the investigator, would interfere with or serves as a contraindication to protocol adherence or a participant's parent's/legally acceptable representative's ability to give informed consent. 18. Participant is a direct descendant (child or grandchild) of any person employed by the Sponsor, the CRO, the PI or study site personnel.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Geometric Mean Concentration Using WC3 as the Viral Lysate | 28 day after last dose of the study vaccine | GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unsolicited Adverse Events | From first vaccination through 4 weeks after the last vaccination. | Percentage of participants reporting unsolicited AEs at a rate \>5%. |
| Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate | 28 days after last dose of study vaccine. | Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if a baseline concentration is \< 20 U/mL or a post-vaccination serum anti-rotavirus IgA antibody concentration of ≥ 2-fold baseline level if a baseline concentration is ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®. |
| Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 28 days after last dose of study vaccine | Seropositivity is defined as serum anti-rotavirus IgA antibody concentration ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®. |
| Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 28 days after last dose of study vaccine | Seroresponse will be assessed as a four-fold, three-fold and two- fold rise in antibody concentration from baseline. Seroresponse will be assessed as a four-fold, three-fold and two-fold rise in antibody concentration from baseline. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®. |
| Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | At 28 days after last dose of study vaccine in reference to baseline. | GMFR in each of the ROTAVAC 5D®, ROTAVAC® and Rotarix® vaccine arms. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®. |
| Immediate Adverse Events | within 30 minutes' post-vaccination. | Percentage of participants reporting immediate adverse events after each vaccination |
| Solicited Adverse Events | 7 day period after each vaccination. | Percentage of participants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level) |
| Serious Adverse Events | From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity | Percentage of participants reporting SAEs |
Other
| Measure | Time frame | Description |
|---|---|---|
| Seropositivity Using Strain 89-12 as the Viral Lysate | at baseline and 28 days after last dose of study vaccine | Seropositivity rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®. |
| Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate | at 28 days after last dose of study vaccine in reference to baseline. | GMFR in the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®. |
| Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate | 28 days after the last dose of a study vaccine. | GMCs of serum anti-rotavirus IgA antibodies in each of the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®. |
| Seroconversion Using Strain 89-12 as the Viral Lysate | 28 days after the last dose of a study vaccine. | Seroconversion rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®. |
Countries
Zambia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ROTAVAC 5D® ROTAVAC 5D® administered at 6, 10 and 14 weeks of age. | 150 |
| ROTAVAC® ROTAVAC® administered at 6, 10 and 14 weeks of age. | 150 |
| Rotarix® Rotarix® administered at 6 and 10 weeks of age. | 150 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 6 | 0 |
| Overall Study | migration | 2 | 3 | 0 |
| Overall Study | Other | 1 | 0 | 0 |
| Overall Study | Physician Decision | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 3 | 0 | 4 |
| Overall Study | Withdrawal by Subject | 7 | 9 | 7 |
Baseline characteristics
| Characteristic | ROTAVAC 5D® | Total | Rotarix® | ROTAVAC® |
|---|---|---|---|---|
| Age, Continuous | 6.56 weeks STANDARD_DEVIATION 0.477 | 6.55 weeks STANDARD_DEVIATION 0.475 | 6.60 weeks STANDARD_DEVIATION 0.491 | 6.50 weeks STANDARD_DEVIATION 0.473 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 150 Participants | 450 Participants | 150 Participants | 150 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Zambia | 150 participants | 450 participants | 150 participants | 150 participants |
| Sex: Female, Male Female | 66 Participants | 209 Participants | 66 Participants | 77 Participants |
| Sex: Female, Male Male | 84 Participants | 241 Participants | 84 Participants | 73 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 150 | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 93 / 137 | 95 / 139 | 81 / 142 |
| serious Total, serious adverse events | 2 / 137 | 1 / 139 | 3 / 142 |
Outcome results
Primary
Geometric Mean Concentration Using WC3 as the Viral Lysate
GMC of serum anti-rotavirus IgA antibodies as measured by enzyme linked immunosorbent assay (ELISA) using WC3 (heterologous to vaccine strain) as the viral lysate. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC 5D® and ROTAVAC®.
Time frame: 28 day after last dose of the study vaccine
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ROTAVAC 5D® | Geometric Mean Concentration Using WC3 as the Viral Lysate | 18.1 U/ml |
| ROTAVAC® | Geometric Mean Concentration Using WC3 as the Viral Lysate | 14.0 U/ml |
95% CI: [0.862, 1.924]t-test, 2 sided
Secondary
Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
GMFR in each of the ROTAVAC 5D®, ROTAVAC® and Rotarix® vaccine arms. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Time frame: At 28 days after last dose of study vaccine in reference to baseline.
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ROTAVAC 5D® | Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 4.6 Fold rise |
| ROTAVAC® | Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 3.6 Fold rise |
| Rotarix® | Geometric Mean Fold Rise (GMFR) in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 3.8 Fold rise |
Secondary
Immediate Adverse Events
Percentage of participants reporting immediate adverse events after each vaccination
Time frame: within 30 minutes' post-vaccination.
Population: The analysis was performed on Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ROTAVAC 5D® | Immediate Adverse Events | 1 Participants |
| ROTAVAC® | Immediate Adverse Events | 0 Participants |
| Rotarix® | Immediate Adverse Events | 1 Participants |
Secondary
Serious Adverse Events
Percentage of participants reporting SAEs
Time frame: From first vaccination through 4 weeks after the last vaccination of each study participant. Immunogenicity
Population: The analysis was performed on Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVAC 5D® | Serious Adverse Events | Any SAEs | 2 Participants |
| ROTAVAC 5D® | Serious Adverse Events | Diarrhoea | 1 Participants |
| ROTAVAC 5D® | Serious Adverse Events | Bronchiolitis | 1 Participants |
| ROTAVAC 5D® | Serious Adverse Events | Sepsis | 0 Participants |
| ROTAVAC® | Serious Adverse Events | Sepsis | 1 Participants |
| ROTAVAC® | Serious Adverse Events | Any SAEs | 1 Participants |
| ROTAVAC® | Serious Adverse Events | Bronchiolitis | 0 Participants |
| ROTAVAC® | Serious Adverse Events | Diarrhoea | 0 Participants |
| Rotarix® | Serious Adverse Events | Sepsis | 1 Participants |
| Rotarix® | Serious Adverse Events | Diarrhoea | 0 Participants |
| Rotarix® | Serious Adverse Events | Bronchiolitis | 2 Participants |
| Rotarix® | Serious Adverse Events | Any SAEs | 3 Participants |
Secondary
Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seroconversion is defined as a post-vaccination serum anti-rotavirus IgA antibody concentration of at least 20 U/mL if a baseline concentration is \< 20 U/mL or a post-vaccination serum anti-rotavirus IgA antibody concentration of ≥ 2-fold baseline level if a baseline concentration is ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Time frame: 28 days after last dose of study vaccine.
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ROTAVAC 5D® | Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate | 52 Participants |
| ROTAVAC® | Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate | 41 Participants |
| Rotarix® | Seroconversion Rate in Each of the Three Arms as Measured by ELISA Using WC3 as the Viral Lysate | 50 Participants |
Secondary
Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seropositivity is defined as serum anti-rotavirus IgA antibody concentration ≥ 20 U/mL. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Time frame: 28 days after last dose of study vaccine
Population: Analysis was performed on the Total Vaccinated Cohort.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ROTAVAC 5D® | Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 54 Participants |
| ROTAVAC® | Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 42 Participants |
| Rotarix® | Seropositivity Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | 52 Participants |
Secondary
Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate
Seroresponse will be assessed as a four-fold, three-fold and two- fold rise in antibody concentration from baseline. Seroresponse will be assessed as a four-fold, three-fold and two-fold rise in antibody concentration from baseline. WC3 strain of rotavirus used in the ELISA assay was heterologous to the 116E strain contained in the vaccines ROTAVAC® and ROTAVAC 5D®.
Time frame: 28 days after last dose of study vaccine
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVAC 5D® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Three-fold rise | 71 Participants |
| ROTAVAC 5D® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Four-fold rise | 61 Participants |
| ROTAVAC 5D® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Two-fold rise | 79 Participants |
| ROTAVAC® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Two-fold rise | 65 Participants |
| ROTAVAC® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Three-fold rise | 55 Participants |
| ROTAVAC® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Four-fold rise | 49 Participants |
| Rotarix® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Two-fold rise | 74 Participants |
| Rotarix® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Four-fold rise | 58 Participants |
| Rotarix® | Seroresponse Rate in Each of the Three Vaccine Arms as Measured by ELISA Using WC3 as the Viral Lysate | Seroresponse rate- Three-fold rise | 66 Participants |
Secondary
Solicited Adverse Events
Percentage of participants reporting solicited post-vaccination reactogenicity (fever, diarrhea, vomiting, decreased appetite, irritability, decreased activity level)
Time frame: 7 day period after each vaccination.
Population: The analysis was performed on Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVAC 5D® | Solicited Adverse Events | Irritability | 105 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Decreased activity level | 62 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Diarrhea | 15 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Fever | 110 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Vomiting | 14 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Decreased appetite | 53 Participants |
| ROTAVAC 5D® | Solicited Adverse Events | Any Solicited AEs | 138 Participants |
| ROTAVAC® | Solicited Adverse Events | Decreased appetite | 44 Participants |
| ROTAVAC® | Solicited Adverse Events | Decreased activity level | 66 Participants |
| ROTAVAC® | Solicited Adverse Events | Any Solicited AEs | 136 Participants |
| ROTAVAC® | Solicited Adverse Events | Irritability | 109 Participants |
| ROTAVAC® | Solicited Adverse Events | Fever | 109 Participants |
| ROTAVAC® | Solicited Adverse Events | Vomiting | 14 Participants |
| ROTAVAC® | Solicited Adverse Events | Diarrhea | 11 Participants |
| Rotarix® | Solicited Adverse Events | Irritability | 101 Participants |
| Rotarix® | Solicited Adverse Events | Any Solicited AEs | 129 Participants |
| Rotarix® | Solicited Adverse Events | Fever | 100 Participants |
| Rotarix® | Solicited Adverse Events | Vomiting | 15 Participants |
| Rotarix® | Solicited Adverse Events | Decreased appetite | 44 Participants |
| Rotarix® | Solicited Adverse Events | Decreased activity level | 55 Participants |
| Rotarix® | Solicited Adverse Events | Diarrhea | 8 Participants |
Secondary
Unsolicited Adverse Events
Percentage of participants reporting unsolicited AEs at a rate \>5%.
Time frame: From first vaccination through 4 weeks after the last vaccination.
Population: The analysis was performed on Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ROTAVAC 5D® | Unsolicited Adverse Events | Rhinitis | 21 Participants |
| ROTAVAC 5D® | Unsolicited Adverse Events | Conjunctivitis | 10 Participants |
| ROTAVAC 5D® | Unsolicited Adverse Events | Any Unsolicited AEs | 93 Participants |
| ROTAVAC 5D® | Unsolicited Adverse Events | Diarrhoea | 18 Participants |
| ROTAVAC 5D® | Unsolicited Adverse Events | Upper respiratory tract infection | 52 Participants |
| ROTAVAC® | Unsolicited Adverse Events | Any Unsolicited AEs | 95 Participants |
| ROTAVAC® | Unsolicited Adverse Events | Rhinitis | 12 Participants |
| ROTAVAC® | Unsolicited Adverse Events | Upper respiratory tract infection | 46 Participants |
| ROTAVAC® | Unsolicited Adverse Events | Conjunctivitis | 10 Participants |
| ROTAVAC® | Unsolicited Adverse Events | Diarrhoea | 17 Participants |
| Rotarix® | Unsolicited Adverse Events | Diarrhoea | 11 Participants |
| Rotarix® | Unsolicited Adverse Events | Conjunctivitis | 6 Participants |
| Rotarix® | Unsolicited Adverse Events | Rhinitis | 10 Participants |
| Rotarix® | Unsolicited Adverse Events | Any Unsolicited AEs | 81 Participants |
| Rotarix® | Unsolicited Adverse Events | Upper respiratory tract infection | 39 Participants |
Other Pre-specified
Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate
GMCs of serum anti-rotavirus IgA antibodies in each of the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.
Time frame: 28 days after the last dose of a study vaccine.
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ROTAVAC 5D® | Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate | 20.6 Au/ml |
| ROTAVAC® | Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate | 19.2 Au/ml |
| Rotarix® | Geometric Mean Concentrations Using Strain 89-12 as the Viral Lysate | 38.0 Au/ml |
Other Pre-specified
Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate
GMFR in the three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.
Time frame: at 28 days after last dose of study vaccine in reference to baseline.
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| ROTAVAC 5D® | Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate | 4.8 Fold rise |
| ROTAVAC® | Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate | 4.9 Fold rise |
| Rotarix® | Geometric Mean Fold Rise (GMFR) Using Strain 89-12 as the Viral Lysate | 8.8 Fold rise |
Other Pre-specified
Seroconversion Using Strain 89-12 as the Viral Lysate
Seroconversion rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.
Time frame: 28 days after the last dose of a study vaccine.
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ROTAVAC 5D® | Seroconversion Using Strain 89-12 as the Viral Lysate | 24 Participants |
| ROTAVAC® | Seroconversion Using Strain 89-12 as the Viral Lysate | 18 Participants |
| Rotarix® | Seroconversion Using Strain 89-12 as the Viral Lysate | 26 Participants |
Other Pre-specified
Seropositivity Using Strain 89-12 as the Viral Lysate
Seropositivity rate in three vaccine arms. 89-12 strain of Rotavirus used in the ELISA assay was homologous to Rotarix® and was heterologous to the strain contained in ROTAVAC® and ROTAVAC 5D®.
Time frame: at baseline and 28 days after last dose of study vaccine
Population: The analysis was performed on Per Protocol Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ROTAVAC 5D® | Seropositivity Using Strain 89-12 as the Viral Lysate | 25 Participants |
| ROTAVAC® | Seropositivity Using Strain 89-12 as the Viral Lysate | 18 Participants |
| Rotarix® | Seropositivity Using Strain 89-12 as the Viral Lysate | 27 Participants |