| Primary | Number and Percentage of Subjects With Demonstrated Seropositivity for Japanese Encephalitis (JE) Neutralizing Antibodies | Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. Seropositivity was defined as a titer of ≥1:10. | Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28). | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Day 0 | | |
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| Primary | Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Manufacturer Definition | Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with "borderline" results (≥150 mIU/mL). | Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28). | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Primary | Number and Percentage of Subjects With Demonstrated Seropositivity for Anti-measles Immunoglobulin G (IgG): Including Borderline Subjects | Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL) and when including those with "borderline" results (≥150 mIU/mL, this table). | Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28). | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Geometric Mean Titer (GMT) of Japanese Encephalitis (JE) Neutralizing Antibodies | Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum neutralizing antibodies to the Beijing-1 JE strain were measured by plaque reduction neutralization test (PRNT) where the neutralizing titer was measured as the inverse dilution at which plaque counts were reduced by 50%. | Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28). | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Geometric Mean Titer (GMT) of Anti-measles Immunoglobulin G (IgG) | Blood serum was collected immediately before administration (Day 0), Day 28, six months post-administration, and 1 year later. Serum anti-measles immunoglobulin class G (IgG) antibodies were measured by enzyme-linked immunosorbent assay (ELISA) (Serion ELISA classic Measles Virus IgG, Serion GmbH, Würzburg,Germany). For anti-measles IgG, two definitions of seropositivity were used: per manufacturer's instruction (concentration of>200 mIU/mL, this table) and when including those with "borderline" results (≥150 mIU/mL). | Of the 278 enrolled, 257 participants were determined to meet criteria at 28 days weeks post-co-administration with study vaccines (13 were found to have been out of range for age at inclusion, 4 did not have the Day 28 blood specimen collected within range, and 4 were not able to provide sera at Day 28). | Posted | | Geometric Mean | 95% Confidence Interval | titer | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number and Percentage of Subjects With Immediate Reactions, Local and Systemic Reactions, and Unsolicited Adverse Events (AE) | Subjects were monitored for immediate AEs and local reactions for 30 minutes after each injection by a study physician. Thereafter, parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days afterwards. Study staff called the subjects' parents 2 days after vaccination and monthly through 1 year to inquire about the child's well being and review the diary card. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. The subject returned to the vaccination clinic on Day 28, 6 months, and 1 year to be examined, have a blood draw, and review any AEs or serious adverse events (SAE) with parents. | Not all subjects were followed for a full 30 minutes after injection. | Posted | | Count of Participants | | Participants | | 1 year | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Local Reactions to LJEV: Days 0-3 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 3 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Local Reactions to LJEV: Days 4-7 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 4 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Local Reactions to Measles Vaccine: Days 0-3 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 3 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Local Reactions to Measles Vaccine: Days 4-7 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 4 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Systemic Reactions: Days 0-3 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 3 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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| Secondary | Number of Solicited Systemic Reactions: Days 4-7 | Parents recorded axillary temperature, local reactions (redness, swelling, pain, and other local reactions), and systemic symptoms (high-grade fever, anorexia, crying, diarrhea, drowsiness, insomnia, irritability, vomiting, and other systemic symptoms) in a study diary for 7 days after vaccination. The subject was visited at home on Day 7 to review and collect the reactogenicity diary card. | | Posted | | Number | | reactions | | 4 days | | | | ID | Title | Description |
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| OG000 | All Subjects | Healthy infants 9 months of age (plus or minus 2 weeks) that met the eligibility criteria. Subjects received one dose of Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine (LJEV) and one dose of live, attenuated measles vaccine. Live, Attenuated Japanese Encephalitis SA 14-14-2 Vaccine: Manufactured by Chengdu Institute of Biological Products (CDIBP), Chengdu, China; batch 200611A078-1. Administered subcutaneously in the right brachium. Live, attenuated measles vaccine: Manufactured by Serum Institute of India, Ltd, Pune, India; batch EU3244. Administered subcutaneously in the left brachium. |
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