Trial Outcomes & Findings for Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035) (NCT NCT00432042)
NCT ID: NCT00432042
Last Updated: 2018-03-19
Results Overview
The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
955 participants
Primary outcome timeframe
Day 42
Results posted on
2018-03-19
Participant Flow
A total of 963 participants were screened at study centers in Italy and Germany.
Participant milestones
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 3: Infanrix® Hexa
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|---|
|
Overall Study
STARTED
|
479
|
235
|
241
|
|
Overall Study
Vaccinated
|
477
|
235
|
240
|
|
Overall Study
COMPLETED
|
472
|
234
|
239
|
|
Overall Study
NOT COMPLETED
|
7
|
1
|
2
|
Reasons for withdrawal
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 3: Infanrix® Hexa
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
5
|
1
|
0
|
Baseline Characteristics
Immunogenicity and Safety Study of Proquad® and Infanrix® Hexa When Administered Concomitantly (V221-035)
Baseline characteristics by cohort
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=479 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=235 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 3: Infanrix® Hexa
n=241 Participants
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Total
n=955 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
13.6 Months
STANDARD_DEVIATION 1.9 • n=93 Participants
|
13.4 Months
STANDARD_DEVIATION 1.5 • n=4 Participants
|
13.5 Months
STANDARD_DEVIATION 1.7 • n=27 Participants
|
13.5 Months
STANDARD_DEVIATION 1.7 • n=483 Participants
|
|
Sex: Female, Male
Female
|
222 Participants
n=93 Participants
|
112 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
448 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
257 Participants
n=93 Participants
|
123 Participants
n=4 Participants
|
127 Participants
n=27 Participants
|
507 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: Day 42Population: Participants in Arm 1 and Arm 2 who were initially seronegative to measles, mumps, rubella, or varicella; had post-vaccination serology results; and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 3 was not planned it was not included.
The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 2: ProQuad® was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: measles antibody titre ≥255 mIU/mL in participants with baseline titre \<255 mIU/mL; mumps antibody titre ≥10 ELISA Ab units/mL in participants with baseline titre \<10 ELISA Ab units mL; rubella antibody titre ≥10 IU/mL in participants with baseline titre \<10 IU/mL; varicella antibody titre ≥5 gpELISA units/mL in participants with baseline titre \<1.25 gpELISA units/mL. Measles, mumps and rubella antibody levels were determined using enzyme-linked immunosorbent assay (ELISA) and varicella antibody levels were determined with glycoprotein-based ELISA (gpELISA).
Outcome measures
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=431 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=215 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|
|
Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella
Measles
|
97.4 Percentage of Participants
Interval 95.4 to 98.7
|
96.3 Percentage of Participants
Interval 92.8 to 98.4
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella
Mumps
|
96.7 Percentage of Participants
Interval 94.6 to 98.2
|
98.6 Percentage of Participants
Interval 95.9 to 99.7
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella
Rubella
|
97.9 Percentage of Participants
Interval 96.1 to 99.0
|
99.1 Percentage of Participants
Interval 96.7 to 99.9
|
|
Percentage of Participants Meeting Antibody Response Rate Criteria to Measles, Mumps, Rubella, and Varicella
Varicella
|
97.7 Percentage of Participants
Interval 95.7 to 99.0
|
95.1 Percentage of Participants
Interval 91.2 to 97.6
|
PRIMARY outcome
Timeframe: Day 42Population: Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.
The percentage of participants with seronegative baseline values who met antibody response criteria in Arm 1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa was determined. Post-vaccination antibody response and baseline seronegativity criteria were as follows: Hepatitis B antibody titre ≥10 IU/mL and Haemophilus Influenzae Type b antibody titre ≥1 ug/mL. Hepatitis B antibody levels were determined using anti-HBs ORTHO ECi Immunodiagnostic Assay. Haemophilus Influenzae Type b antibody (anti-polyribosylribitol phosphate \[PRP\]) levels were determined with radioimmunoassay (RIA) or with enzyme immunoassay (EIA).
Outcome measures
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=411 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=215 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|
|
Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B
Hepatitis B
|
99.5 Percentage of participants
Interval 98.3 to 99.9
|
98.1 Percentage of participants
Interval 95.3 to 99.5
|
|
Percentage of Participants Meeting Post-vaccination Antibody Response Rates to Hepatitis B and Haemophilus Influenzae Type B
Haemophilus Influenzae Type B
|
98.2 Percentage of participants
Interval 96.3 to 99.3
|
95.3 Percentage of participants
Interval 91.5 to 97.7
|
PRIMARY outcome
Timeframe: Day 42Population: Participants in Arm 1 and Arm 3 who had post-vaccination serology results and who did not have protocol violations that may have interfered with immunogenicity results were included. As analysis of Arm 2 was not planned it was not included.
The GMT to pertussis were compared in Arm1: ProQuad® + Infanrix® hexa and Arm 3: Infanrix® hexa. Anti-pertussis toxin (anti-PT), anti-filamentous hemagglutinin (anti-FHA), and anti-pertactin (anti-PRN) were determined using ELISA on solid phase based on sandwich principle.
Outcome measures
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=386 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=211 Participants
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|
|
Post-vaccination Geometric Mean Titres (GMT) to Pertussis
Anti-PT GMT
|
132.6 GMT (IU/mL)
Interval 123.8 to 142.0
|
139.1 GMT (IU/mL)
Interval 126.7 to 152.8
|
|
Post-vaccination Geometric Mean Titres (GMT) to Pertussis
Anti-FHA GMT
|
210.9 GMT (IU/mL)
Interval 195.7 to 227.2
|
189.9 GMT (IU/mL)
Interval 170.2 to 211.8
|
|
Post-vaccination Geometric Mean Titres (GMT) to Pertussis
Anti-PRN GMT
|
310.0 GMT (IU/mL)
Interval 282.2 to 340.7
|
259.7 GMT (IU/mL)
Interval 226.3 to 298.1
|
Adverse Events
Arm 1: ProQuad® + Infanrix® Hexa
Serious events: 7 serious events
Other events: 409 other events
Deaths: 0 deaths
Arm 2: ProQuad®
Serious events: 6 serious events
Other events: 134 other events
Deaths: 0 deaths
Infanrix® Hexa
Serious events: 4 serious events
Other events: 184 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=474 participants at risk
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=234 participants at risk
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Infanrix® Hexa
n=239 participants at risk
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.00%
0/474 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
1.3%
3/234 • Number of events 3 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.42%
1/239 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Bronchopneumonia
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.43%
1/234 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/474 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.43%
1/234 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Gastroenteritis
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.43%
1/234 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.42%
1/239 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Influenza
|
0.00%
0/474 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.42%
1/239 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Otitis media
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/474 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.43%
1/234 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Urinary tract infection
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.21%
1/474 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Injury, poisoning and procedural complications
Electric shock
|
0.00%
0/474 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.42%
1/239 • Number of events 1 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Nervous system disorders
Febrile convulsion
|
0.42%
2/474 • Number of events 2 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/234 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.00%
0/239 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
Other adverse events
| Measure |
Arm 1: ProQuad® + Infanrix® Hexa
n=474 participants at risk
Pediatric (12 to 23 months of age) participants received ProQuad® and Infanrix® hexa (booster dose) concomitantly on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Arm 2: ProQuad®
n=234 participants at risk
Pediatric (12 to 23 months of age) participants received ProQuad® on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
Infanrix® Hexa
n=239 participants at risk
Pediatric (12 to 23 months of age) participants received Infanrix® hexa (booster dose) on Visit 1 (Day 0). Blood samples were taken on Visit 1 and Visit 2 (Day 42).
|
|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.6%
22/474 • Number of events 23 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
6.0%
14/234 • Number of events 14 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
5.9%
14/239 • Number of events 14 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
14/474 • Number of events 15 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
0.85%
2/234 • Number of events 2 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
5.9%
14/239 • Number of events 15 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
General disorders
Injection site erythema
|
57.8%
274/474 • Number of events 338 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
13.2%
31/234 • Number of events 31 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
52.7%
126/239 • Number of events 131 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
General disorders
Injection site pain
|
41.8%
198/474 • Number of events 285 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
14.1%
33/234 • Number of events 33 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
35.1%
84/239 • Number of events 84 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
General disorders
Injection site swelling
|
42.8%
203/474 • Number of events 235 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
3.0%
7/234 • Number of events 7 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
38.9%
93/239 • Number of events 93 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
General disorders
Pyrexia
|
38.8%
184/474 • Number of events 263 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
34.2%
80/234 • Number of events 104 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
28.5%
68/239 • Number of events 91 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Bronchitis
|
5.7%
27/474 • Number of events 28 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
5.1%
12/234 • Number of events 12 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
5.0%
12/239 • Number of events 12 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Nasopharyngitis
|
10.1%
48/474 • Number of events 50 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
6.0%
14/234 • Number of events 16 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
7.5%
18/239 • Number of events 18 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Infections and infestations
Rhinitis
|
5.7%
27/474 • Number of events 28 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
8.5%
20/234 • Number of events 23 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
3.8%
9/239 • Number of events 10 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.5%
31/474 • Number of events 32 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
5.6%
13/234 • Number of events 15 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
4.6%
11/239 • Number of events 11 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
|
Skin and subcutaneous tissue disorders
Rash morbilliform
|
7.0%
33/474 • Number of events 36 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
6.8%
16/234 • Number of events 16 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
2.1%
5/239 • Number of events 6 • Up to Day 42
All participants who received at least one dose of study vaccine and who have safety follow-up data are included.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sanofi Pasteur MSD shall have sixty days to review these documents and may refuse to give its consent in part or whole for confidential reasons (including but not limited to intellectual property rights, whether patentable or not).
- Publication restrictions are in place
Restriction type: OTHER